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

December 27, 2007 updated by: Emory University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Winship Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Drug: Gleevec, Taxotere
Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.
Other Names:
  • Imatinib, Mesylate, Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine if combination of Gleevec and Taxotere is effective treatment for incurable stomach cancer.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine toxicity of combination of Gleevec and Taxotere.
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Novartis

Investigators

  • Principal Investigator: John Kauh, MD, Emory University Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 31, 2007

Last Update Submitted That Met QC Criteria

December 27, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0804-2004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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