A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Observed response rate, calculated as the percent of evaluable patients whose best response is a CR or PR
Associated exact 95% confidence intervals will be calculated.
Up to 9 years
University of Southern California
United States: Food and Drug Administration
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