Stage IV Gastric Cancer Clinical Trial
Official title:
A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles. | No |
Secondary | Overall Survival | Overall survival was estimated according to the Kaplan-Meier product-limit method. | 18 months | No |
Secondary | Progression-free Survival | Progression-free survival was estimated according to the Kaplan-Meier product-limit method | 18 months | No |
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