Phase
Condition
Fallopian Tube Cancer
Peritoneal Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
Sydney Heamatology and Oncology Clinics
Hornsby, New South Wales 2077
AustraliaSite Not Available
Lismore Base Hospital
Lismore, New South Wales 2480
AustraliaSite Not Available
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
Royal North Shore Hospital
St. Leonards, New South Wales 2065
AustraliaSite Not Available
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales 2050
AustraliaSite Not Available
Tamworth Base Hospital
Tamworth, New South Wales 2340
AustraliaSite Not Available
Manning Base Hospital
Taree, New South Wales 2430
AustraliaSite Not Available
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales 2298
AustraliaSite Not Available
Westmead Institute for Cancer Research at Westmead Hospital
Wentworthville, New South Wales 2145
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Brisbane, Queensland 4029
AustraliaSite Not Available
Townsville Hospital
Douglas, Queensland 4814
AustraliaSite Not Available
Mater Adult Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, South Australia 5042
AustraliaSite Not Available
Royal Hobart Hospital
Hobart, Tasmania 7000
AustraliaSite Not Available
Ballarat Oncology and Haematology Services
Ballarat, Victoria 3350
AustraliaSite Not Available
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaSite Not Available
Royal Women's Hospital
Carlton, Victoria 3053
AustraliaSite Not Available
Monash Medical Center - Clayton Campus
Clayton, Victoria 3168
AustraliaSite Not Available
Frankston Hospital
Frankston, Victoria 3199
AustraliaSite Not Available
Mercy Hospital for Women
Heidelberg, Victoria 3084
AustraliaSite Not Available
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria 3690
AustraliaSite Not Available
Auckland City Hospital
Auckland, 1
New ZealandSite Not Available
Christchurch Hospital
Christchurch, 1
New ZealandSite Not Available
Waikato Hospital
Hamilton, 2020
New ZealandSite Not Available
Wellington Cancer Centre
Wellington, 6039
New ZealandSite Not Available
Furness General Hospital
Barrow in Furness, England LA14 4LF
United KingdomSite Not Available
Royal United Hospital
Bath, England BA1 3NG
United KingdomSite Not Available
Birmingham Heartlands Hospital
Birmingham, England B9 5SS
United KingdomSite Not Available
Royal Blackburn Hospital
Blackburn, England BB2 3HH
United KingdomSite Not Available
Blackpool Victoria Hospital
Blackpool, England FY3 8NR
United KingdomSite Not Available
Bradford Royal Infirmary
Bradford, England BD9 6RJ
United KingdomSite Not Available
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England BN2 5BE
United KingdomSite Not Available
Bristol Haematology and Oncology Centre
Bristol, England BS2 8ED
United KingdomSite Not Available
Broomfield Hospital
Broomfield, England CM1 7ET
United KingdomSite Not Available
Queen's Hospital
Burton-upon-Trent, England DE13 0RB
United KingdomSite Not Available
Cheltenham General Hospital
Cheltenham, England GL53 7AN
United KingdomSite Not Available
Essex County Hospital
Colchester, England C03 3NB
United KingdomSite Not Available
Walsgrave Hospital
Coventry, England CV2 2DX
United KingdomSite Not Available
Derbyshire Royal Infirmary
Derby, England DE1 2QY
United KingdomSite Not Available
Dorset County Hospital
Dorchester, England DT1 2JY
United KingdomSite Not Available
Russells Hall Hospital
Dudley, England DY1 2HQ
United KingdomSite Not Available
Gloucestershire Royal Hospital
Gloucester, England GL1 3NN
United KingdomSite Not Available
Hereford Hospitals NHS Trust
Hereford, England HR1 2ER
United KingdomSite Not Available
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England HD3 3EA
United KingdomSite Not Available
Ipswich Hospital
Ipswich, England IP4 5PD
United KingdomSite Not Available
Airedale General Hospital
Keighley, England BD20 6TD
United KingdomSite Not Available
Royal Lancaster Infirmary
Lancaster, England LA1 4RP
United KingdomSite Not Available
Leeds Cancer Centre at St. James's University Hospital
Leeds, England LS9 7TF
United KingdomSite Not Available
Leicester Royal Infirmary
Leicester, England LE1 5WW
United KingdomSite Not Available
Liverpool Women's Hospital
Liverpool, England LV8 7SS
United KingdomSite Not Available
Guy's Hospital
London, England SE1 9RT
United KingdomSite Not Available
Hammersmith Hospital
London, England W12 OHS
United KingdomSite Not Available
Saint Bartholomew's Hospital
London, England EC1A 7BE
United KingdomSite Not Available
St. Georges, University of London
London, England SW17 0QT
United KingdomSite Not Available
University College of London Hospitals
London, England NW1 2PG
United KingdomSite Not Available
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England ME16 9QQ
United KingdomSite Not Available
Christie Hospital
Manchester, England M20 4BX
United KingdomSite Not Available
Queen Elizabeth The Queen Mother Hospital
Margate, England CT9 4AN
United KingdomSite Not Available
Clatterbridge Centre for Oncology
Merseyside, England CH63 4JY
United KingdomSite Not Available
Northampton General Hospital NHS Trust
Northampton, England NN1 5BD
United KingdomSite Not Available
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England HA6 2RN
United KingdomSite Not Available
Nottingham City Hospital NHS Trust
Nottingham, England NG5 1PB
United KingdomSite Not Available
Kings Mill Hospital
Nottinghamshire, England NG17 4JL
United KingdomSite Not Available
George Eliot Hospital
Nuneaton, England CV10 7DJ
United KingdomSite Not Available
Whiston Hospital
Prescot Merseyside, England L35 5DR
United KingdomSite Not Available
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England PR2 9HT
United KingdomSite Not Available
Alexandra Healthcare NHS
Redditch, Worcestershire, England B98 7UB
United KingdomSite Not Available
Cancer Research Centre at Weston Park Hospital
Sheffield, England S1O 2SJ
United KingdomSite Not Available
Wexham Park Hospital
Slough, Berkshire, England SL2 4HL
United KingdomSite Not Available
Royal Marsden - Surrey
Sutton, England SM2 5PT
United KingdomSite Not Available
Taunton and Somerset Hospital
Taunton Somerset, England TA1 5DA
United KingdomSite Not Available
South Warwickshire Hospital
Warwick, Warwickshire, England CV34 5BJ
United KingdomSite Not Available
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England SS0 0RY
United KingdomSite Not Available
Weston General Hospital
Weston-super-Mare, England BS23 4TQ
United KingdomSite Not Available
Worcester Royal Hospital
Worcester, England WR5 1DD
United KingdomSite Not Available
Worthing Hospital
Worthing, England BN11 2DH
United KingdomSite Not Available
Yeovil District Hospital
Yeovil - Somerset, England BA21 4AT
United KingdomSite Not Available
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland BT9 7BL
United KingdomSite Not Available
Aberdeen Royal Infirmary
Aberdeen, Scotland AB25 2ZN
United KingdomSite Not Available
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland DG1 4AP
United KingdomSite Not Available
Ninewells Hospital
Dundee, Scotland DD1 9SY
United KingdomSite Not Available
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland EH4 2XR
United KingdomSite Not Available
Gartnavel General Hospital
Glasgow, Scotland G12 0YN
United KingdomSite Not Available
Raigmore Hospital
Inverness, Scotland 1V2 3UJ
United KingdomSite Not Available
Ysbyty Gwynedd
Bangor, Wales LL57 2PW
United KingdomSite Not Available
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales CF4 7XL
United KingdomSite Not Available
West Wales General Hospital
Carmarthen, Wales SA31 2AF
United KingdomSite Not Available
South West Wales Cancer Institute
Swansea, Wales SA2 8QA
United KingdomSite Not Available
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