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

Phase 2

Completed

• Conditions: Stage IV Gastric Cancer; Stage III Gastric Cancer
• Interventions: Drug: bryostatin 1; Drug: cisplatin; Other: laboratory biomarker analysis

• Registration Number: NCT00006389
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 2000-10
• Study First Submitted: 2000-10-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-10
• Results First Submitted: 2014-09-26
• Results First Submitted QC: 2014-09-26
• Last Update Submitted: 2014-09-26
• Results First Posted: 2014-10-01
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	laboratory biomarker analysis	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	cisplatin	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	bryostatin 1	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.

Primary Outcome Measures

Name	Time	Method
Observed Response Rate.	Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.	All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 "target lesions" were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference; The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	18 months	Overall survival was estimated according to the Kaplan-Meier product-limit method.
Progression-free Survival	18 months	Progression-free survival was estimated according to the Kaplan-Meier product-limit method

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States