RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer.

Condition	Treatment or Intervention	Phase
stage III gastric cancer stage IV gastric cancer	Drug: bryostatin 1  Drug: cisplatin  Procedure: chemosensitization/potentiation  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.
• Determine the toxic effects of this regimen in these patients.
• 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.

PROJECTED ACCRUAL: A total of 15-62 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic or unresectable carcinoma of the stomach
• Measurable disease
• No brain metastasis

PATIENT CHARACTERISTICS: Age:

• Over 18

Performance status:

• Karnofsky 70-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• 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

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• Transaminases no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min

Other:

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• More than 4 weeks since prior major surgery
• Prior incomplete resection allowed

Other:

• No other prior antitumor treatment

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States
      City of Hope Medical Group, Pasadena,  California,  91105,  United States
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States

Study chairs or principal investigators

Heinz-Josef Lenz, MD,  Study Chair,  University of Southern California   

Study ID Numbers:  CDR0000068267; LAC-USC-3S001; CHNMC-PHII-22; NCI-T99-0040
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006389
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08