NCT00006389

Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer

A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.

Detailed description

OBJECTIVES: 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.

Conditions

• Stage III Gastric Cancer
• Stage IV Gastric Cancer

Interventions

Type	Name	Description
DRUG	bryostatin 1	Given IV
DRUG	cisplatin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2003-01-27
• Last updated: 2014-10-01
• Results posted: 2014-10-01

Locations

1 site across 1 country: United States