Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal carcinoma Prior surgery required within the past 12 weeks Either optimal (no greater than 1 cm residual disease) or suboptimal residual disease following initial surgery No ovarian epithelial tumors of low malignant potential (borderline tumor) The following histologic epithelial cell types are eligible: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater than 2.5 times ULN No acute hepatitis Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within past 6 months Abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for past 6 months Other: No septicemia or severe infection No severe gastrointestinal bleeding No concurrent or prior invasive malignancies within past 5 years except nonmelanoma skin cancer No greater than grade 1 neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: No prior cancer treatment that contraindicates study protocol

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Study ID:

NCT00005026

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 47 Locations for this study

See Locations Near You

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Community Hospital of Los Gatos
Los Gatos California, 95032, United States
University of Colorado Cancer Center
Denver Colorado, 80010, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Tampa Bay Cancer Consortium
Saint Petersburg Florida, 33701, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
Radiation Oncology Branch
Bethesda Maryland, 20892, United States
Tufts University School of Medicine
Boston Massachusetts, 02111, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Ellis Fischel Cancer Center
Columbia Missouri, 65203, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Cooper Hospital/University Medical Center
Camden New Jersey, 08103, United States
Cancer Center of Albany Medical Center
Albany New York, 12208, United States
State University of New York Health Science Center at Brooklyn
Brooklyn New York, 11203, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11790, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Barrett Cancer Center, The University Hospital
Cincinnati Ohio, 45219, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma College of Medicine
Oklahoma City Oklahoma, 73190, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Brookview Research, Inc.
Nashville Tennessee, 37203, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Cancer Center at the University of Virginia
Charlottesville Virginia, 22908, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Tacoma General Hospital
Tacoma Washington, 98405, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Study ID:

NCT00005026

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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