Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.
OBJECTIVES: I. Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin. II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
University of Southern California
Los Angeles, California, United States
Observed Response Rate.
All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 "target lesions" were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval.
Time frame: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.
Overall Survival
Overall survival was estimated according to the Kaplan-Meier product-limit method.
Time frame: 18 months
Progression-free Survival
Progression-free survival was estimated according to the Kaplan-Meier product-limit method
Time frame: 18 months
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