Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy
Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease Ascites and pleural effusions are not considered measurable disease Sonography acceptable provided lesions are clearly defined on initial examination and bidimensionally measurable Must have had 1 prior platinum based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease Initial treatment may include high dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment No additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens Must be considered platinum resistant or refractory Treatment free interval of less than 6 months following platinum or progression during platinum based therapy No known brain metastases Must not be eligible for a higher priority GOG protocol 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 no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection requiring antibiotics No evidence of preexisting peripheral sensory neuropathy greater than grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy At least 3 weeks since prior immunotherapy No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No more than 1 prior chemotherapy regimen If initial therapy did not include paclitaxel, a second regimen including paclitaxel is allowed At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignant tumor Concurrent continuation of hormone replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to sites of measurable disease used on this trial No prior radiotherapy to greater than 25% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)
Sites / Locations
- University of Alabama Comprehensive Cancer Center
- CCOP - Greater Phoenix
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Chao Family Comprehensive Cancer Center
- Women's Cancer Center
- University of Colorado Cancer Center
- Vincent T. Lombardi Cancer Research Center, Georgetown University
- Walter Reed Army Medical Center
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital - Atlanta
- MBCCOP - Hawaii
- MBCCOP - University of Illinois at Chicago
- Rush-Presbyterian-St. Luke's Medical Center
- University of Chicago Cancer Research Center
- CCOP - Evanston
- CCOP - Central Illinois
- Indiana University Cancer Center
- CCOP - Iowa Oncology Research Association
- University of Iowa Hospitals and Clinics
- Albert B. Chandler Medical Center, University of Kentucky
- Johns Hopkins Oncology Center
- Medicine Branch
- Radiation Oncology Branch
- Tufts University School of Medicine
- University of Massachusetts Memorial Medical Center
- CCOP - Ann Arbor Regional
- Barbara Ann Karmanos Cancer Institute
- University of Minnesota Cancer Center
- University of Mississippi Medical Center
- Keesler Medical Center - Keesler AFB
- Ellis Fischel Cancer Center
- CCOP - Kansas City
- Washington University School of Medicine
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- CCOP - Missouri Valley Cancer Consortium
- CCOP - Southern Nevada Cancer Research Foundation
- Cooper Hospital/University Medical Center
- Cancer Center of Albany Medical Center
- State University of New York Health Science Center at Brooklyn
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- University of Rochester Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- Lineberger Comprehensive Cancer Center, UNC
- Duke Comprehensive Cancer Center
- Brookview Research, Inc.
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Barrett Cancer Center, The University Hospital
- Ireland Cancer Center
- Cleveland Clinic Cancer Center
- Arthur G. James Cancer Hospital - Ohio State University
- University of Oklahoma College of Medicine
- CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
- CCOP - Columbia River Program
- Abington Memorial Hospital
- Milton S. Hershey Medical Center
- University of Pennsylvania Cancer Center
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Pennsylvania Hospital
- Fox Chase Cancer Center
- CCOP - MainLine Health
- Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- CCOP - Baptist Cancer Institute
- Simmons Cancer Center - Dallas
- University of Texas - MD Anderson Cancer Center
- CCOP - Scott and White Hospital
- Cancer Center, University of Virginia HSC
- University of Washington Medical Center
- Tacoma General Hospital
- NCIC-Clinical Trials Group