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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Cisplatin

Criteria

Inclusion Criteria:

• Diagnosis of metastatic or unresectable carcinoma of the stomach

• Measurable disease

• No brain metastasis

• Performance status - Karnofsky 70-100%

• More than 3 months

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

• No history of any bleeding disorders

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 2 times normal

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No history of peptic ulceration or gastrointestinal bleeding

• No active infection

• No seizure disorder

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other serious concurrent illness that would preclude study entry

• No medical, social, or psychological factors that would preclude study entry

• No prior chemotherapy

• No prior radiotherapy

• More than 4 weeks since prior major surgery

• Prior incomplete resection allowed

• No other prior antitumor treatment