Gastric Cancer Clinical Trial
Official title:
A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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