Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT00098878 | Completed Phase 3

• 4 other identifiers: SCOTTISH-SCOTROC-4CDR0000396778EU-20402ISRCTN47645935
• Study Type: interventional
• Target: 1,300
• Locations: 3 countries
• Sites: 88

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (4)

• Toxicity

• Quality of life

• Clinical overall response rate and CA125 response

• Overall survival

Interventions

carboplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (88)

Sydney Heamatology and Oncology Clinics

Hornsby, New South Wales, 2077, Australia

Location

Lismore Base Hospital

Lismore, New South Wales, 2480, Australia

Location

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Tamworth Base Hospital

Tamworth, New South Wales, 2340, Australia

Location

Manning Base Hospital

Taree, New South Wales, 2430, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Westmead Institute for Cancer Research at Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Ballarat Oncology and Haematology Services

Ballarat, Victoria, 3350, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Royal Women's Hospital

Carlton, Victoria, 3053, Australia

Location

Monash Medical Center - Clayton Campus

Clayton, Victoria, 3168, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Mercy Hospital for Women

Heidelberg, Victoria, 3084, Australia

Location

Murray Valley Private Hospital and Cancer Treatment Centre

Wodonga, Victoria, 3690, Australia

Location

Auckland City Hospital

Auckland, 1, New Zealand

Location

Christchurch Hospital

Christchurch, 1, New Zealand

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Wellington Cancer Centre

Wellington, 6039, New Zealand

Location

Furness General Hospital

Barrow in Furness, England, LA14 4LF, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, England, BB2 3HH, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Bradford Royal Infirmary

Bradford, England, BD9 6RJ, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Broomfield Hospital

Broomfield, England, CM1 7ET, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Hereford Hospitals NHS Trust

Hereford, England, HR1 2ER, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Airedale General Hospital

Keighley, England, BD20 6TD, United Kingdom

Location

Royal Lancaster Infirmary

Lancaster, England, LA1 4RP, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Liverpool Women's Hospital

Liverpool, England, LV8 7SS, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

University College of London Hospitals

London, England, NW1 2PG, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

St. Georges, University of London

London, England, SW17 0QT, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Queen Elizabeth The Queen Mother Hospital

Margate, England, CT9 4AN, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, England, NN1 5BD, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Kings Mill Hospital

Nottinghamshire, England, NG17 4JL, United Kingdom

Location

George Eliot Hospital

Nuneaton, England, CV10 7DJ, United Kingdom

Location

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Alexandra Healthcare NHS

Redditch, Worcestershire, England, B98 7UB, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Taunton and Somerset Hospital

Taunton Somerset, England, TA1 5DA, United Kingdom

Location

South Warwickshire Hospital

Warwick, Warwickshire, England, CV34 5BJ, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1DD, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Yeovil District Hospital

Yeovil - Somerset, England, BA21 4AT, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Dumfries & Galloway Royal Infirmary

Dumfries, Scotland, DG1 4AP, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XR, United Kingdom

Location

Gartnavel General Hospital

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

West Wales General Hospital

Carmarthen, Wales, SA31 2AF, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Stanley B. Kaye, MD, FRCP

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: March 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2009-07

Locations

GB (63); NZ (4); AU (21)