Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer, recurrent ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, Brenner tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial carcinoma including the following cellular diagnoses: Serous adenocarcinoma Mucinous adenocarcinoma Endometrioid adenocarcinoma Clear cell adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Stage III (optimal or suboptimal) must be surgically reassessed OR Stage III (suboptimal) or stage IV clinically reassessed after induction chemotherapy For stage III surgical reassessment: No more than 12 weeks between end of chemotherapy and reassessment surgery AND No more than 6 weeks between reassessment surgery and randomization Patients treated on protocol GOG-158 are eligible At least a partial response to chemotherapy as defined as: Microscopic disease documented at reassessment surgery for patients optimally debulked (disease no greater than 1 cm) after primary surgery Suboptimally debulked disease (greater than 1 cm) after primary surgery and 1 of the following: Negative reassessment laparotomy Only microscopic disease at reassessment surgery Gross residual disease no greater than 1 cm at reassessment surgery prior to debulking Clinical complete response to induction chemotherapy including: - suboptimal disease Stage III or IV AND - either an abnormal CT or elevated CA-125 prior to induction chemotherapy and both are within normal limits following induction chemotherapy PATIENT CHARACTERISTICS: Age: Under 66 Performance status: GOG 0 or 1 Hematopoietic: Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% by MUGA No congestive heart failure Pulmonary: FEV1 and FVC at least 60% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy in the past 5 years except adequately treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose prior treatment does not contraindicate this study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 and no more than 6 prior platinum-based combination chemotherapy courses (i.e., cisplatin or carboplatin) required Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior anthracyclines
Sites / Locations
- Veterans Affairs Medical Center - Birmingham
- University of California San Diego Cancer Center
- UCSF Cancer Center and Cancer Research Institute
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Walter Reed Army Medical Center
- CCOP - Mount Sinai Medical Center
- Sylvester Cancer Center, University of Miami
- H. Lee Moffitt Cancer Center and Research Institute
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Veterans Affairs Medical Center - Chicago (Lakeside)
- University of Illinois at Chicago Health Sciences Center
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Iowa Oncology Research Association
- University of Iowa Hospitals and Clinics
- Veterans Affairs Medical Center - Togus
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- New England Medical Center Hospital
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- University of Massachusetts Memorial Medical Center
- CCOP - Kalamazoo
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- CCOP - Metro-Minnesota
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- CCOP - Northern New Jersey
- Albert Einstein Comprehensive Cancer Center
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- Mount Sinai Medical Center, NY
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- Lineberger Comprehensive Cancer Center, UNC
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- CCOP - Merit Care Hospital
- Hahnemann University Hospital
- Rhode Island Hospital
- Medical University of South Carolina
- Veterans Affairs Medical Center - Memphis
- University of Tennessee, Memphis Cancer Center
- Veterans Affairs Medical Center - Nashville
- Vanderbilt Cancer Center
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- Veterans Affairs Medical Center - Richmond
- MBCCOP - Massey Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation