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Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix

Phase 2
Completed
Conditions
Cervical Cancer
Registration Number
NCT00005965
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of bryostatin-1 plus cisplatin in treating patients who have recurrent or advanced cancer of the cervix.

Detailed Description

OBJECTIVES: I. Determine the safety and efficacy of bryostatin-1 plus cisplatin in patients with recurrent or advanced carcinoma of the cervix. II. Determine the response rate, progression free interval, and duration of survival of these patients when treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive bryostatin-1 IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed until death.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study over 2-3 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

Saint Vincent Catholic Medical Center of New York

🇺🇸

New York, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center

🇺🇸

New York, New York, United States

New York Presbyterian Hospital - Cornell Campus

🇺🇸

New York, New York, United States

Mount Sinai Medical Center, NY

🇺🇸

New York, New York, United States

Albert Einstein Comprehensive Cancer Center

🇺🇸

Bronx, New York, United States

New York Medical College

🇺🇸

Valhalla, New York, United States

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