## Protocol Section
### Identification Module
**NCT ID:** NCT00209079

**Brief Title:** Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

**Official Title:** Phase II Trial of Gleevec (Imatinib Mesylate) and Taxotere (Docetaxel) as a Combined Regimen for Advanced Gastric Adenocarcinoma

#### Organization Study ID Info
**ID:** 0804-2004
#### Organization
**Class:** OTHER
**Full Name:** Emory University
### Status Module
#### Completion Date
**Date:** 2007-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2007-12-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-12-27

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2007-04

**Type:** ACTUAL

#### Start Date
**Date:** 2004-09

**Status Verified Date:** 2007-09

#### Study First Post Date
**Date:** 2005-09-21
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-14
**Study First Submit QC Date:** 2005-09-14
**Why Stopped:** Terminated 4/17/07. Drug sponsor withdrew.
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Novartis

#### Lead Sponsor

**Class:** OTHER

**Name:** Emory University

#### Responsible Party

**Old Name Title:** John Kauh, MD

**Old Organization:** Winship Cancer Institute

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

**Detailed Description:** The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. Gleevec is a pill form of chemotherapy and is indicated for the treatment of adult patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is considered experimental for the treatment of stomach cancer. Taxotere (docetaxel) is a chemotherapy which is injected into the vein. It is approved for breast and lung cancer but has been shown to shrink many different types of tumors. Taxotere has been shown to shrink stomach cancer in about 20% - 30% of patients treated with Taxotere only. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

Treatment on this study consists of two drugs, Gleevec® and Taxotere. Patients will be take four tablets of Gleevec® daily throughout the study. After one week of Gleevec®, patients will then begin receiving doses of Taxotere intravenously once a week for two weeks in a row followed by one week without Taxotere.

### Conditions Module

**Conditions:**

- Gastric Adenocarcinoma

**Keywords:**

- Gastric Adenocarcinoma

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 5

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Gleevec, Taxotere

**Label:** 1

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.

**Name:** Gleevec, Taxotere

**Other Names:**

- Imatinib, Mesylate, Docetaxel

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Determine if combination of Gleevec and Taxotere is effective treatment for incurable stomach cancer.

**Time Frame:** 3 months

#### Secondary Outcomes

**Measure:** Determine toxicity of combination of Gleevec and Taxotere.

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* This study is for patients with histologically confirmed unresectable gastric adenocarcinoma and who have not received any chemotherapy other than 5-FU for adjuvant therapy either alone or in conjunction with radiation.

Exclusion Criteria:

* Patients may not have received any chemotherapy agents other than 5-FU.
* Patients may not have received 5-FU for for therapy for metastatic gastric cancer.
* Patients must be more than 5 years free of another primary malignancy except: if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
* Patients must not have Grade III/IV cardiac problems, or any severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
* Patient must not have had previously received radiotherapy to \>/= 25% of the bone marrow, or have had major surgery within 2 weeks prior to study entry
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University Winship Cancer Institute

**State:** Georgia

**Zip:** 30322

#### Overall Officials

**Official 1:**

**Affiliation:** Emory University Winship Cancer Institute

**Name:** John Kauh, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3585

- Name: Adenocarcinoma

- Relevance: HIGH

- As Found: Adenocarcinoma

- 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

### Condition Browse Module - Meshes

- ID: D000000230

- Term: Adenocarcinoma

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000092004

- Term: Tyrosine Kinase Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M1668

- Name: Docetaxel

- Relevance: HIGH

- As Found: Fat

- ID: M324

- Name: Imatinib Mesylate

- Relevance: HIGH

- As Found: Time points

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- 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: D000077143

- Term: Docetaxel

- ID: D000068877

- Term: Imatinib Mesylate

### Misc Info Module

- Version Holder: 2024-05-24
