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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage IV Gastric Cancer; Stage III Gastric Cancer

Treatments: Other: laboratory biomarker analysis; Drug: cisplatin; Drug: bryostatin 1

Study type: Interventional

Funder types: NIH

Identifiers

NCT00006389

N01CM17101 (U.S. NIH Grant/Contract)

T99-0040 (Other Identifier)

CHNMC-PHII-22

NCI-2012-02361 (Registry Identifier)

NCI-T99-0040

CDR0000068267

PHII-22 (USC 3S-00-1) (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Drug: bryostatin 1

Other: laboratory biomarker analysis

Drug: cisplatin