Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer* Stage IC-IV disease Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor Stage IC patients must have malignant cells in ascitic fluid or peritoneal washings, tumor on the surface of the ovary, or preoperative capsule rupture NOTE: * Histologic confirmation of a primary source in the ovary is not required. If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met: Patient has a pelvis (ovarian) mass AND all of the following: Omental cake or other metastasis is larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size OR stage IV disease Serum CA 125/CEA ratio > 25 or barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) are negative for the presence of a primary tumor and normal mammography within 6 weeks prior to study randomization Initial cytoreductive laparotomy or biopsy required within the past 8 weeks Cytoreductive surgery may or may not have been successful during staging laparotomy No mixed mesodermal tumors No borderline ovarian tumors or tumors termed "possibly malignant" No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor Considered unsuitable for or unwilling to receive platinum-taxane combination therapy No concurrent endometrial cancer PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 5 times ULN Renal Creatinine clearance ≥ 30 mL/min Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance 30-45 mL/min) renal function must be treated before study entry Cardiovascular No hypertension No ischemic heart disease No myocardial infarction within the past 6 months No congestive heart failure Other Not pregnant or nursing Fertile patients must use effective contraception No symptomatic peripheral neuropathy ≥ grade 2 No uncontrolled infection No other severe and/or uncontrolled medical condition No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy No other concurrent cytotoxic chemotherapy until progressive disease occurs Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery See Disease Characteristics
Sites / Locations
- Sydney Heamatology and Oncology Clinics
- Lismore Base Hospital
- Institute of Oncology at Prince of Wales Hospital
- Royal North Shore Hospital
- Sydney Cancer Centre at Royal Prince Alfred Hospital
- Tamworth Base Hospital
- Manning Base Hospital
- Newcastle Mater Misericordiae Hospital
- Westmead Institute for Cancer Research at Westmead Hospital
- Royal Brisbane and Women's Hospital
- Townsville Hospital
- Mater Adult Hospital
- Flinders Medical Centre
- Royal Hobart Hospital
- Ballarat Oncology and Haematology Services
- Box Hill Hospital
- Royal Women's Hospital
- Monash Medical Center - Clayton Campus
- Frankston Hospital
- Mercy Hospital for Women
- Murray Valley Private Hospital and Cancer Treatment Centre
- Auckland City Hospital
- Christchurch Hospital
- Waikato Hospital
- Wellington Cancer Centre
- Furness General Hospital
- Royal United Hospital
- Birmingham Heartlands Hospital
- Royal Blackburn Hospital
- Blackpool Victoria Hospital
- Bradford Royal Infirmary
- Sussex Cancer Centre at Royal Sussex County Hospital
- Bristol Haematology and Oncology Centre
- Broomfield Hospital
- Queen's Hospital
- Cheltenham General Hospital
- Essex County Hospital
- Walsgrave Hospital
- Derbyshire Royal Infirmary
- Dorset County Hospital
- Russells Hall Hospital
- Gloucestershire Royal Hospital
- Hereford Hospitals NHS Trust
- Huddersfield Royal Infirmary
- Ipswich Hospital
- Airedale General Hospital
- Royal Lancaster Infirmary
- Leeds Cancer Centre at St. James's University Hospital
- Leicester Royal Infirmary
- Liverpool Women's Hospital
- Saint Bartholomew's Hospital
- University College of London Hospitals
- Guy's Hospital
- St. Georges, University of London
- Hammersmith Hospital
- Mid Kent Oncology Centre at Maidstone Hospital
- Christie Hospital
- Queen Elizabeth The Queen Mother Hospital
- Clatterbridge Centre for Oncology
- Northampton General Hospital NHS Trust
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Kings Mill Hospital
- Nottingham City Hospital NHS Trust
- George Eliot Hospital
- Whiston Hospital
- Rosemere Cancer Centre at Royal Preston Hospital
- Alexandra Healthcare NHS
- Cancer Research Centre at Weston Park Hospital
- Wexham Park Hospital
- Royal Marsden - Surrey
- Taunton and Somerset Hospital
- South Warwickshire Hospital
- Southend University Hospital NHS Foundation Trust
- Weston General Hospital
- Worcester Royal Hospital
- Worthing Hospital
- Yeovil District Hospital
- Centre for Cancer Research and Cell Biology at Queen's University Belfast
- Aberdeen Royal Infirmary
- Dumfries & Galloway Royal Infirmary
- Ninewells Hospital
- Edinburgh Cancer Centre at Western General Hospital
- Gartnavel General Hospital
- Raigmore Hospital
- Ysbyty Gwynedd
- Velindre Cancer Center at Velindre Hospital
- West Wales General Hospital
- South West Wales Cancer Institute