Gastric Cancer Clinical Trial
Official title:
Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer
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.
;
Masking: Open Label, Primary Purpose: Treatment
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