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 bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer.
OBJECTIVES: * Determine the complete and partial response rates in patients with unresectable or metastatic esophageal cancer or carcinoma of the gastroesophageal junction treated with sequential paclitaxel and bryostatin 1. * Determine the toxicity of this regimen in this patient population. * Determine the survival of patients after treatment with this regimen. * Determine the quality of life of patients treated with this regimen. * Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day 2 weekly for 2 weeks. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, after courses 1 and 2, and then after every 2 courses thereafter. PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 1-2 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
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