## Protocol Section
### Identification Module
**NCT ID:** NCT00266279

**Brief Title:** Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

**Official Title:** Phase II Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

#### Organization Study ID Info
**ID:** 153.05
#### Organization
**Class:** OTHER
**Full Name:** University of Louisville
### Status Module
#### Completion Date
**Date:** 2009-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-09-03

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-10-31

**Type:** ESTIMATED

**Results First Submit Date:** 2013-05-03

**Results First Submit QC Date:** 2014-10-30

#### Start Date
**Date:** 2005-04

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2005-12-16
**Type:** ESTIMATED
**Study First Submit Date:** 2005-12-15
**Study First Submit QC Date:** 2005-12-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** James Graham Brown Cancer Center

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Louisville

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This phase II study will test the response rate of combined oxaliplatin and capecitabine treatment when administered at a given dose and schedule, in patients with Head and Neck cancer for which there is no curative treatment.

**Detailed Description:** The optimal dose and schedule for the combined treatment with oxaliplatin and capecitabine have not been defined. The aim of this Phase II study is to determine the response rate of combined oxaliplatin and capecitabine treatment at a given dose and schedule in patients with Head and Neck cancer for which there is no curative treatment.

The study also aims to determine the qualitative and quantitative toxicity and reversibility of toxicity of the above combination and to evaluate any changes in performance status, quality of life, overall survival and progression-free survival.

### Conditions Module

**Conditions:**

- Head or Neck Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 17

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.

**Intervention Names:**

- Drug: Oxaliplatin, Capecitabine

**Label:** Treatment with Study Drugs

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment with Study Drugs

**Description:** Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21

**Name:** Oxaliplatin, Capecitabine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria.

Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Overall Response Rate (ORR)=PR+CR.

**Measure:** Overall Response Rate

**Time Frame:** Every two 28 day treatment cycles until subject no longer on treatment due to disease progression

#### Secondary Outcomes

**Description:** Number of patients that developed common side effect of diarrhea.

**Measure:** Qualitative and Quantitative Toxicity

**Time Frame:** At study enrollment, Every two 28 day treatment cycles, and at end of treatment due to disease progression

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients must have histologically or cytologically confirmed squamous cell cancer of Head and Neck
* Patients must have metastatic or locally recurrent disease
* Patients must have disease not curable by surgery as estimated by one of the protocol investigators, and should not be eligible for reradiation protocol or have failed reradiation protocol.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan
* Age \>18 years of age
* Life expectancy of greater than 12 weeks
* ECOG performance status 0, 1 or 2 (Karnofsky \>50%; see Appendix B)
* Patients must have adequate bone marrow function as defined below:

  * absolute neutrophil count \> 1,500
  * platelets \> 100,000
  * hemoglobin \> 8 g/dl
* Patients must have adequate renal function as defined by a creatinine clearance \>30 mL/min (measured or estimated by the Cockroft and Gault equation)

  * Cockroft and Gault equation:
  * Creatinine clearance for males =(140-age\[yrs\])(body wt\[kg\])/72(serum creatinine\[mg/dL\])
  * Creatinine clearance for females = 0.85 x male value
* Patients must have adequate liver function as defined below:

  * total bilirubin 1.5x upper limit of normal
  * albumin \> 2.5 g/dl
  * AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be \< 5 times upper limit of normal
* Patients could have received 1 or 2 previous chemotherapy regimens prior to entering the study. Patients must have recovered from acute toxicities from chemotherapy or radiotherapy administered prior to entering this study. Alopecia may not be resolved and peripheral neuropathy (grade 1) may be present.
* Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil or oxaliplatin
* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to first treatment in this study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients receiving any other investigational agent(s)
* Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events)
* Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ
* Clinically significant cardiac disease (e.g. congestive heart failure, New York Heart Association Class II or greater, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
* If patient is unable to swallow, xeloda may be crushed per hospital policy/procedure. See attached Appendix G.
* Patients who have had an organ allograft.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnancy
* Known Hepatitis B , Hepatitis C, HIV

Inclusion of Minorities:

Members of all ethnic groups are eligible for this trial.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Louisville

**Country:** United States

**Facility:** University of Louisville, James Graham Brown Cancer Center

**State:** Kentucky

**Zip:** 40202

#### Overall Officials

**Official 1:**

**Affiliation:** University of Louisville, James Graham Brown Cancer Center

**Name:** Damian Laber, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Rabinowits G, Bhupalam L, Miller DM, Kloecker GH, Laber DA. Fixed-dose every-other-week capecitabine and oxaliplatin for refractory squamous cell carcinoma of the head and neck. Am J Med Sci. 2010 Feb;339(2):148-51. doi: 10.1097/MAJ.0b013e3181c4bd91.

**PMID:** 20087165

#### See Also Links

**Label:** James Graham Brown Cancer Center website

**URL:** http://browncancercenter.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: HIGH

- As Found: Neck Cancer

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M377

- Name: Capecitabine

- Relevance: HIGH

- As Found: Function

- ID: M1674

- Name: Oxaliplatin

- Relevance: HIGH

- As Found: Outcomes

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069287

- Term: Capecitabine

- ID: D000077150

- Term: Oxaliplatin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Treatment With Study Drugs

**Description:** Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.

Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21

**ID:** EG000

**Other Num at Risk:** 15

**Serious Number Affected:** 4

**Serious Number At Risk:** 15

**Title:** Treatment With Study Drugs

**Frequency Threshold:** 5

#### Serious Events

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Two patients were hospitalized because of pneumonia.

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 15

**Num Events:** 2

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** 1 subjects was hospitalized for dehydration.

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 15

**Num Events:** 1

**Term:** Gastrointestinal Bleeding

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** 1 Subject experienced gastrointestinal bleeding.

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 15

**Num Events:** 1

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 15

**Units:** Participants

### Group

**ID:** BG000

**Title:** Treatment With Study Drugs

**Description:** Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.

Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

**Class Title:** >=18 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

**Class Title:** Male

#### Measurement

**Group ID:** BG000

**Value:** 5

**Class Title:** Femal

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** NUMBER
**Title:** Sex/Gender, Customized
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Results data not available, PI not longer at institution
### Point of Contact
**Email:** bcccto@louisville.edu
**Organization:** University of Louisville, James Graham Brown Cancer Center
**Phone:** 502-562-3429
**Title:** University of Louisville, James Graham Brown Cancer Center Clinical Trials
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria.

Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Overall Response Rate (ORR)=PR+CR.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Every two 28 day treatment cycles until subject no longer on treatment due to disease progression
**Title:** Overall Response Rate
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.

Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
**ID:** OG000
**Title:** Treatment With Study Drugs
#### Outcome Measure 2
**Description:** Number of patients that developed common side effect of diarrhea.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** At study enrollment, Every two 28 day treatment cycles, and at end of treatment due to disease progression
**Title:** Qualitative and Quantitative Toxicity
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.

Oxaliplatin, Capecitabine: Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
**ID:** OG000
**Title:** Treatment With Study Drugs
### Participant Flow Module
#### Group
**Description:** Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.

Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
**ID:** FG000
**Title:** Treatment With Study Drugs
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 15
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
**Has Results:** True