S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian Cancer
Ovarian Cancer, Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring peritoneal cavity cancer, recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial carcinoma Stage III or IV disease at time of initial staging laparotomy Primary peritoneal and mixed Mullerian tumors allowed No borderline ovarian tumors Disease progression or recurrence after a progression-free and platinum-free interval of 6-24 months after completion of first-line platinum-based chemotherapy (either single agent or combination therapy) Disease progression or recurrence based solely on CA 125 elevation allowed, provided that one of the following is true: Prior baseline CA 125 greater than 35 U/mL and subsequent normalization of no greater than 35 U/mL must have CA 125 greater than 2 times upper limit of normal (ULN) on 2 occasions at least 1 week apart Prior baseline CA 125 greater than 35 U/mL that never normalized must have CA 125 greater than 2 times the nadir value on 2 occasions at least 1 week apart Prior normal baseline CA 125 (no greater than 35 U/mL) must show CA 125 greater than 2 times ULN on 2 occasions at least 1 week apart No known brain metastases PATIENT CHARACTERISTICS: Age Not specified Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Bilirubin no greater than ULN Renal Creatinine no greater than 1.9 mg/dL Cardiovascular No New York Heart Association class II-IV cardiac disease No clinical evidence of congestive heart failure Ejection fraction greater than 50% by MUGA or 2-dimensional echocardiogram Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid cancer No evidence of active or uncontrolled infection No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding or diarrhea No greater than grade 1 preexisting sensory neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy At least 28 days since prior biologic consolidation therapy No concurrent immunotherapy Chemotherapy See Disease Characteristics At least 28 days since prior non-platinum-containing consolidation chemotherapy No prior pegylated doxorubicin HCl liposome No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose in excess of 240 mg/m^2 No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Radiotherapy No prior abdominopelvic irradiation No concurrent radiotherapy Surgery See Disease Characteristics At least 28 days since prior surgical debulking for disease progression or recurrence and recovered No concurrent surgery Other No other prior treatment during the 6-24 month progression-free and platinum-free interval except up to 12 courses of consolidation therapy No other concurrent anticancer therapy
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock
- City of Hope Comprehensive Cancer Center
- California Cancer Center at Woodward Park Office
- Veterans Affairs Medical Center - Loma Linda (Pettis)
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of California Davis Cancer Center
- CCOP - Santa Rosa Memorial Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- MBCCOP - Howard University Cancer Center
- Veterans Affairs Medical Center - Tampa (Haley)
- CCOP - Atlanta Regional
- MBCCOP - Hawaii
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Veterans Affairs Medical Center - New Orleans
- Veterans Affairs Medical Center - Shreveport
- Louisiana State University Health Sciences Center - Shreveport
- Cancer Research Center at Boston Medical Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Health System
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Cancer Institute at Providence Hospital - Southfield
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- CCOP - Kansas City
- St. Louis University Hospital Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma University Medical Center
- Cancer Institute at Oregon Health and Science University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- University of Tennessee Cancer Institute at Methodist Central Hospital
- Veterans Affairs Medical Center - Memphis
- Harrington Cancer Center
- Veterans Affairs Medical Center - Amarillo
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Veterans Affairs Medical Center - Seattle
- Puget Sound Oncology Consortium
- CCOP - Northwest
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
carboplatin and doxorubicin
carboplatin
carboplatin and liposomal doxorubicin given q 4 weeks
carboplatin alone