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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stage III Gastric Cancer Stage IV Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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.

Group Type EXPERIMENTAL

bryostatin 1

Intervention Type DRUG

Given IV

cisplatin

Intervention Type DRUG

Given IV

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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bryostatin 1

Given IV

Intervention Type DRUG

cisplatin

Given IV

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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B705008K112 BRYO Bryostatin CACP CDDP CPDD DDP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No