Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer

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

Study ID: NCT00006081

Conditions

Esophageal Cancer

Gastric Cancer

Interventions

Bryostatin-1

Paclitaxel (Taxol)

Study Description

Brief Summary: 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.

Detailed Description: 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.