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Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

NCT ID: NCT00209079

Last Updated: 2007-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-04-30

Brief Summary

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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

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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

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Gastric Adenocarcinoma

Keywords

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Gastric Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Gleevec, Taxotere

Intervention Type DRUG

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

Interventions

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Gleevec, Taxotere

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

Intervention Type DRUG

Other Intervention Names

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Imatinib, Mesylate, Docetaxel

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Winship Cancer Institute

Principal Investigators

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John Kauh, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

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Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0804-2004

Identifier Type: -

Identifier Source: org_study_id