## Protocol Section
### Identification Module
**NCT ID:** NCT00835679

**Brief Title:** Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery

**Official Title:** A Preoperative Biological Trial of Cetuximab, Dasatinib or the Combination in Colorectal Cancer Patients With Resectable Liver Metastases

#### Organization Study ID Info
**ID:** NCI-2013-00014
#### Organization
**Class:** NIH
**Full Name:** National Cancer Institute (NCI)
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2013-00014
**Type:** REGISTRY
**ID:** VU-VICC-GI-0838
**ID:** 8069
**ID:** P30CA068485
**Link:** https://reporter.nih.gov/quickSearch/P30CA068485
**Type:** NIH
**ID:** 081338
**Domain:** Vanderbilt-Ingram Cancer Center
**ID:** VICC GI 0838
**Type:** OTHER
**Domain:** CTEP
**ID:** 8069
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2011-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-05-23

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-05-07

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2011-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-09-07

**Type:** ESTIMATED

**Results First Submit Date:** 2012-03-12

**Results First Submit QC Date:** 2012-08-07

#### Start Date
**Date:** 2009-12

**Status Verified Date:** 2013-01

#### Study First Post Date
**Date:** 2009-02-04
**Type:** ESTIMATED
**Study First Submit Date:** 2009-02-03
**Study First Submit QC Date:** 2009-02-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor cells in patients with colorectal cancer and liver metastases that can be removed by surgery. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

**Detailed Description:** PRIMARY OBJECTIVES:

I. To evaluate the biological effects of cetuximab, dasatinib, or the combination on epidermal growth factor receptor (EGFR)- and Src-signaling pathways in resected colorectal cancer liver metastases.

OUTLINE: This is a multicenter study. Patients are initially enrolled in cohort A. Once cohort A is completed, additional patients are enrolled and randomized to treatment in either cohorts B or C. If a significant biological effect is seen in cohorts B or C, additional patients are enrolled in cohort D.

COHORT A: Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.

COHORT B: Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m\^2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15.

COHORT C: Patients receive dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15.

COHORT D: Patients receive 400 mg/m\^2 cetuximab IV over 120 minutes on day 1 and 250 mg/m\^2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15.

Patients undergo tumor tissue (from initial liver tumor biopsies and liver resection samples), serum, and peripheral blood mononuclear cell sample collection periodically for biomarker analysis via immunohistochemistry (IHC).

### Conditions Module

**Conditions:**

- Liver Metastases

- Mucinous Adenocarcinoma of the Colon

- Mucinous Adenocarcinoma of the Rectum

- Recurrent Colon Cancer

- Recurrent Rectal Cancer

- Signet Ring Adenocarcinoma of the Colon

- Signet Ring Adenocarcinoma of the Rectum

- Stage IV Colon Cancer

- Stage IV Rectal Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.

**Intervention Names:**

- Procedure: therapeutic conventional surgery

- Other: laboratory biomarker analysis

**Label:** Cohort A (no systemic neoadjuvant therapy)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients receive 400 mg/m\^2 cetuximab IV over 120 minutes on day 1 and 250 mg/m\^2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15.

**Intervention Names:**

- Biological: cetuximab

- Procedure: therapeutic conventional surgery

- Other: laboratory biomarker analysis

**Label:** Cohort B (cetuximab)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15.

**Intervention Names:**

- Drug: dasatinib

- Procedure: therapeutic conventional surgery

- Other: laboratory biomarker analysis

**Label:** Cohort C (dasatinib)

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Patients receive 400 mg/m\^2 cetuximab IV over 120 minutes on day 1 and 250 mg/m\^2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15.

**Intervention Names:**

- Biological: cetuximab

- Drug: dasatinib

- Procedure: therapeutic conventional surgery

- Other: laboratory biomarker analysis

**Label:** Cohort D (cetuximab, dasatinib)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort B (cetuximab)

- Cohort D (cetuximab, dasatinib)

**Description:** Given IV

**Name:** cetuximab

**Other Names:**

- C225

- C225 monoclonal antibody

- IMC-C225

- MOAB C225

- monoclonal antibody C225

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Cohort C (dasatinib)

- Cohort D (cetuximab, dasatinib)

**Description:** Given orally

**Name:** dasatinib

**Other Names:**

- BMS-354825

- Sprycel

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Cohort A (no systemic neoadjuvant therapy)

- Cohort B (cetuximab)

- Cohort C (dasatinib)

- Cohort D (cetuximab, dasatinib)

**Description:** Undergo surgery

**Name:** therapeutic conventional surgery

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- Cohort A (no systemic neoadjuvant therapy)

- Cohort B (cetuximab)

- Cohort C (dasatinib)

- Cohort D (cetuximab, dasatinib)

**Description:** Correlative studies

**Name:** laboratory biomarker analysis

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Patients who experienced a pre-to-post treatment reduction of at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker of the pathway being inhibited: epidermal growth factor (EGFR) for Cohort B, sarcoma (Src) for Cohort C, and both EGFR and Src for Cohort D. Blood for these biomarkers will be taken on day of baseline and pre-operatively on day 15. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for pathway in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%).

**Measure:** Patients With a Biologic Response

**Time Frame:** on baseline and preoperatively on day of surgery (day 15)

#### Secondary Outcomes

**Description:** Patients with pre-to-post treatment reduction at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker: total \& phi-EGFR, phi-MAPK, phi-Akt, Ki67, phi-FAK, phi-paxillin, phi-Src, capase 3. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for biomarker in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%)

**Measure:** Patients With Reduction of Biomarkers in Tumor Tissue

**Time Frame:** study entry to day 15

**Description:** Number of patients with each grade of adverse event (AE) during the specified timeframe using the Common Terminology Criteria for AEs guide, grades 1-5 with one being mild, five is death.

**Measure:** Number of Patients With the Given Severity of Adverse Event Within a Specified Duration

**Time Frame:** weekly to day 15, and at followup on day 30

**Measure:** Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration

**Time Frame:** From day 15 (day of surgery) to 30 days after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients must have histologically confirmed adenocarcinoma arising from the large intestine that has metastasized to the liver; liver metastases may be synchronous or metachronous
* The liver metastases must be considered surgically resectable prior to the initiation of study drugs
* Prior chemotherapy or chemoradiotherapy for colorectal cancer is allowed provided that toxicities from prior therapy have resolved to Grade 1 or less; no prior anti-EGFR or anti-Src therapy is allowed
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Absolute neutrophil count \>= 1.5 x 10\^9/L
* Hemoglobin ≥ 9.0 Gm/dL
* Platelets \>= 100 x 10\^9/L
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 5 x institutional upper limit of normal
* Creatinine =\< 1.5 institutional ULN
* Women must have a negative pregnancy test; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
* Although KRAS status will be evaluated in the tumor, wild type KRAS status is not an eligibility criterion

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab or dasatinib
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cetuximab or dasatinib, breastfeeding should be discontinued if the mother is treated with cetuximab or dasatinib
* Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with cetuximab or dasatinib; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
* Patients on potent CYP3A4 inducers and inhibitors

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tampa

**Country:** United States

**Facility:** H. Lee Moffitt Cancer Center and Research Institute

**State:** Florida

**Zip:** 33612

**Location 2:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt-Ingram Cancer Center

**State:** Tennessee

**Zip:** 37232

#### Overall Officials

**Official 1:**

**Affiliation:** Vanderbilt-Ingram Cancer Center

**Name:** Emily Chan

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000008107

- Term: Liver Diseases

- ID: D000018297

- Term: Neoplasms, Cystic, Mucinous, and Serous

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M3585

- Name: Adenocarcinoma

- Relevance: HIGH

- As Found: Adenocarcinoma

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M5545

- Name: Adenocarcinoma, Mucinous

- Relevance: HIGH

- As Found: Mucinous Adenocarcinoma

- ID: M6741

- Name: Cystadenocarcinoma

- Relevance: HIGH

- As Found: Mucinous Adenocarcinoma

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: HIGH

- As Found: Rectal Cancer

- ID: M6338

- Name: Colonic Neoplasms

- Relevance: HIGH

- As Found: Colon Cancer

- ID: M11113

- Name: Liver Neoplasms

- Relevance: HIGH

- As Found: Liver Metastases

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20441

- Name: Neoplasms, Cystic, Mucinous, and Serous

- Relevance: LOW

- As Found: Unknown

- ID: T200

- Name: Adenocarcinoma of the Appendix

- Relevance: HIGH

- As Found: Mucinous Adenocarcinoma

### Condition Browse Module - Meshes

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000012004

- Term: Rectal Neoplasms

- ID: D000003110

- Term: Colonic Neoplasms

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000002288

- Term: Adenocarcinoma, Mucinous

- ID: D000003536

- Term: Cystadenocarcinoma

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000092004

- Term: Tyrosine Kinase Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M315

- Name: Cetuximab

- Relevance: HIGH

- As Found: Appointment

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Program

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: HIGH

- As Found: Chemotherapy

- ID: M10184

- Name: Immunoglobulins

- Relevance: HIGH

- As Found: Program

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M410

- Name: Dasatinib

- Relevance: HIGH

- As Found: Web-

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: HIGH

- As Found: Chemotherapy

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M2889

- Name: Tyrosine Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000068818

- Term: Cetuximab

- ID: D000069439

- Term: Dasatinib

- ID: D000000906

- Term: Antibodies

- ID: D000007136

- Term: Immunoglobulins

- ID: D000000911

- Term: Antibodies, Monoclonal

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** No Treatment Cohort A

**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.

**ID:** EG000

**Other Num at Risk:** 9

**Serious Number At Risk:** 9

**Title:** No Treatment Cohort A

**Group ID:** EG001

**Title:** Cetuximab Cohort B

**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15

**ID:** EG001

**Title:** Cetuximab Cohort B

**Group ID:** EG002

**Title:** Dasatinib Cohort C

**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15

**ID:** EG002

**Title:** Dasatinib Cohort C

**Group ID:** EG003

**Title:** Cetuximab + Dasatiib Cohort D

**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15

**ID:** EG003

**Title:** Cetuximab + Dasatiib Cohort D

**Frequency Threshold:** 5

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 9

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Group ID:** BG003

**Value:** 0

**Group ID:** BG004

**Value:** 9

**Units:** Participants

### Group

**ID:** BG000

**Title:** No Treatment Cohort A

**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.

### Group

**ID:** BG001

**Title:** Cetuximab Cohort B

**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15

### Group

**ID:** BG002

**Title:** Dasatinib Cohort C

**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15

### Group

**ID:** BG003

**Title:** Cetuximab + Dasatiib Cohort D

**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

**Class Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG004

**Value:** 7

**Class Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 2

**Class Title:** >=65 years

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1

**Value:** 58

#### Measurement

**Group ID:** BG004

**Spread:** 1

**Value:** 58

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 5

**Class Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 4

**Class Title:** Male

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG004

**Value:** 9

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**Title:** Age, Categorical
**Unit of Measure:** participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** NUMBER
**Title:** Gender
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** Due to study design and slow accrual, no drug was received, no biomarkers were determined and no data obtained. "0" data is entered in the outcomes measures database as suggested by CT.gov previously. Detailed explanations are given.
### Point of Contact
**Email:** emily.chan@vanderbilt.edu
**Organization:** Vanderbilt-Ingram Cancer Center
**Phone:** 615-343-4677
**Title:** Emily Chan, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
#### Outcome Measure 3
#### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Patients who experienced a pre-to-post treatment reduction of at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker of the pathway being inhibited: epidermal growth factor (EGFR) for Cohort B, sarcoma (Src) for Cohort C, and both EGFR and Src for Cohort D. Blood for these biomarkers will be taken on day of baseline and pre-operatively on day 15. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for pathway in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%).
**Population Description:** No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.
**Reporting Status:** POSTED
**Time Frame:** on baseline and preoperatively on day of surgery (day 15)
**Title:** Patients With a Biologic Response
**Type:** PRIMARY
##### Group
**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
**ID:** OG000
**Title:** No Treatment Cohort A
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG001
**Title:** Cetuximab Cohort B
##### Group
**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG002
**Title:** Dasatinib Cohort C
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG003
**Title:** Cetuximab +Dasatinib Cohort D
#### Outcome Measure 2
**Description:** Patients with pre-to-post treatment reduction at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker: total \& phi-EGFR, phi-MAPK, phi-Akt, Ki67, phi-FAK, phi-paxillin, phi-Src, capase 3. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for biomarker in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%)
**Population Description:** No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.
**Reporting Status:** POSTED
**Time Frame:** study entry to day 15
**Title:** Patients With Reduction of Biomarkers in Tumor Tissue
**Type:** SECONDARY
##### Group
**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
**ID:** OG000
**Title:** No Treatment Cohort A
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG001
**Title:** Cetuximab Cohort B
##### Group
**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG002
**Title:** Dasatinib Cohort C
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG003
**Title:** Cetuximab + Dasatiib Cohort D
#### Outcome Measure 3
**Description:** Number of patients with each grade of adverse event (AE) during the specified timeframe using the Common Terminology Criteria for AEs guide, grades 1-5 with one being mild, five is death.
**Population Description:** No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No patients were accrued to Cohorts B, C, D. This study was closed prematurely due to slow accrual.
**Reporting Status:** POSTED
**Time Frame:** weekly to day 15, and at followup on day 30
**Title:** Number of Patients With the Given Severity of Adverse Event Within a Specified Duration
**Type:** SECONDARY
##### Group
**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
**ID:** OG000
**Title:** No Treatment Cohort A
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG001
**Title:** Cetuximab Cohort B
##### Group
**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15 1-14.
**ID:** OG002
**Title:** Dasatinib Cohort C
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG003
**Title:** Cetuximab + Dasatinib Cohort D
#### Outcome Measure 4
**Population Description:** No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers.No patients received any study drugs. This study was closed prematurely due to slow accrual.
**Reporting Status:** POSTED
**Time Frame:** From day 15 (day of surgery) to 30 days after surgery
**Title:** Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration
**Type:** SECONDARY
##### Group
**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
**ID:** OG000
**Title:** No Treatment Cohort A
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG001
**Title:** Cetuximab Cohort B
##### Group
**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG002
**Title:** Dasatinib Cohort C
##### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
**ID:** OG003
**Title:** Cetuximab + Dasatiib Cohort D
### Participant Flow Module
#### Group
**Description:** Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
**ID:** FG000
**Title:** No Treatment Cohort A
#### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
**ID:** FG001
**Title:** Cetuximab Cohort B
#### Group
**Description:** Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
**ID:** FG002
**Title:** Dasatinib Cohort C
#### Group
**Description:** Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
**ID:** FG003
**Title:** Cetuximab + Dasatiib Cohort D
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
**Pre-Assignment Details:** Eleven patients consented, with two ineligible. The study closed prematurely due to slow accrual.
**Recruitment Details:** This study was open to accrual from December 2009 to August 2011.
**Has Results:** True