Back to resultsBryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Primary Purpose
Stage III Gastric Cancer, Stage IV Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bryostatin 1
cisplatin
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Stage III Gastric Cancer
Eligibility 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
Sites / Locations
- University of Southern California
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm 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.
Outcomes
Primary Outcome Measures
Observed Response Rate.
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
Overall Survival
Overall survival was estimated according to the Kaplan-Meier product-limit method.
Progression-free Survival
Progression-free survival was estimated according to the Kaplan-Meier product-limit method
Full Information
NCT ID
NCT00006389
First Posted
October 4, 2000
Last Updated
September 26, 2014
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00006389
Brief Title
Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Official Title
A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Gastric Cancer, Stage IV Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
bryostatin 1
Other Intervention Name(s)
B705008K112, BRYO, Bryostatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Observed Response Rate.
Description
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.
Time Frame
Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was estimated according to the Kaplan-Meier product-limit method.
Time Frame
18 months
Title
Progression-free Survival
Description
Progression-free survival was estimated according to the Kaplan-Meier product-limit method
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Lenz
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
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