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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine if combination of Gleevec and Taxotere is effective treatment for incurable stomach cancer.
John Kauh, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|