RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.
OBJECTIVES: * Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel. * Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR. Patients are followed until death. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
40 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16).
80 mg/m\^2 one-hour infusion weekly x 3 every 4 weeks
CCOP - M.D. Anderson Research Base
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Number of Patients with Response after 2 Cycles of Treatment
Time frame: 8 Weeks
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