Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00209079|
Recruitment Status : Terminated (Terminated 4/17/07. Drug sponsor withdrew.)
First Posted : September 21, 2005
Last Update Posted : December 31, 2007
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: Gleevec, Taxotere||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Gleevec (Imatinib Mesylate) and Taxotere (Docetaxel) as a Combined Regimen for Advanced Gastric Adenocarcinoma|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
|Active Comparator: 1||
Drug: Gleevec, Taxotere
Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.
Other Name: Imatinib, Mesylate, Docetaxel
- Determine if combination of Gleevec and Taxotere is effective treatment for incurable stomach cancer. [ Time Frame: 3 months ]
- Determine toxicity of combination of Gleevec and Taxotere. [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209079
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||John Kauh, MD||Emory University Winship Cancer Institute|