Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Bryostatin 1

Adjuvants, Immunologic

Immunologic Factors

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.

bryostatin 1

cisplatin

laboratory biomarker analysis

Heinz-Josef Lenz

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.

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.

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

A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer

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.

Overall survival was estimated according to the Kaplan-Meier product-limit method.

Progression-free survival was estimated according to the Kaplan-Meier product-limit method

National Cancer Institute (NCI)

All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.

Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

bryostatin 1: Given IV

cisplatin: Given IV

laboratory biomarker analysis: Correlative studies

Treatment

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Of 12 pts accrued\\treated, none responded. The initial phase accrual goal was 15, but given the 12 non-responders, we determined the probability of 3 future pts all responding (stochastic curtailed sampling) at 2.7%. Decided to terminate the trial.

DCC Project Administrator

The first 15 patients accrued to an Optimal Three-Stage Phase II design. If 3 or more responses are seen then 18 additional evaluable patients will be accrued to the second stage.

Observed Response Rate.

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.

bryostatin 1: Given IV

cisplatin: Given IV

laboratory biomarker analysis: Correlative studies

Spots Global Cancer Trial Database for Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial