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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

Phase 1
Completed
Conditions
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Registration Number
NCT00005026
Lead Sponsor
Gynecologic Oncology Group
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 I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer.

Detailed Description

OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin and topotecan without excessive dose modification or course delay in patients with previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the response rate and progression-free interval in these patients with this treatment regimen. III. Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of carboplatin and topotecan administration in these patients.

OUTLINE: Patients are assigned to one of three treatment regimens. Regimen I: Patients receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on days 1-3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen II: Patients receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes on day 3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen III: Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30 minutes on day 5. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 15-80 patients will be accrued for this study within 2 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 (47)

University of Alabama at Birmingham Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

Community Hospital of Los Gatos

🇺🇸

Los Gatos, California, United States

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

Tampa Bay Cancer Consortium

🇺🇸

Saint Petersburg, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Rush-Presbyterian-St. Luke's Medical Center

🇺🇸

Chicago, Illinois, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

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University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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