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

Last updated: August 6, 2013
Sponsor: NHS Greater Glasgow and Clyde
Overall Status: Completed

Phase

3

Condition

Fallopian Tube Cancer

Peritoneal Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT00098878
SCOTTISH-SCOTROC-4
EU-20402
ISRCTN47645935
CDR0000396778
  • Ages > 18
  • Female

Study 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.

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

Total Participants: 1300
Study Start date:
March 01, 2004
Estimated Completion Date:
July 31, 2010

Study Description

OBJECTIVES:

Primary

  • Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy.

Secondary

  • Compare the toxic effects of these regimens in these patients.

  • Compare the quality of life of patients treated with these regimens.

  • Compare overall clinical response rate and CA 125 response in patients treated with these regimens.

  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive a flat dose of carboplatin on day 1.

  • Arm II: Patients receive intra-patient dose-escalated carboplatin on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each treatment course, and then at 2 months post-chemotherapy.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study.

Connect with a study center

  • Sydney Heamatology and Oncology Clinics

    Hornsby, New South Wales 2077
    Australia

    Site Not Available

  • Lismore Base Hospital

    Lismore, New South Wales 2480
    Australia

    Site Not Available

  • Institute of Oncology at Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St. Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Site Not Available

  • Tamworth Base Hospital

    Tamworth, New South Wales 2340
    Australia

    Site Not Available

  • Manning Base Hospital

    Taree, New South Wales 2430
    Australia

    Site Not Available

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Westmead Institute for Cancer Research at Westmead Hospital

    Wentworthville, New South Wales 2145
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Townsville Hospital

    Douglas, Queensland 4814
    Australia

    Site Not Available

  • Mater Adult Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Ballarat Oncology and Haematology Services

    Ballarat, Victoria 3350
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Royal Women's Hospital

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Monash Medical Center - Clayton Campus

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Mercy Hospital for Women

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Murray Valley Private Hospital and Cancer Treatment Centre

    Wodonga, Victoria 3690
    Australia

    Site Not Available

  • Auckland City Hospital

    Auckland, 1
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, 1
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 2020
    New Zealand

    Site Not Available

  • Wellington Cancer Centre

    Wellington, 6039
    New Zealand

    Site Not Available

  • Furness General Hospital

    Barrow in Furness, England LA14 4LF
    United Kingdom

    Site Not Available

  • Royal United Hospital

    Bath, England BA1 3NG
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, England B9 5SS
    United Kingdom

    Site Not Available

  • Royal Blackburn Hospital

    Blackburn, England BB2 3HH
    United Kingdom

    Site Not Available

  • Blackpool Victoria Hospital

    Blackpool, England FY3 8NR
    United Kingdom

    Site Not Available

  • Bradford Royal Infirmary

    Bradford, England BD9 6RJ
    United Kingdom

    Site Not Available

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England BN2 5BE
    United Kingdom

    Site Not Available

  • Bristol Haematology and Oncology Centre

    Bristol, England BS2 8ED
    United Kingdom

    Site Not Available

  • Broomfield Hospital

    Broomfield, England CM1 7ET
    United Kingdom

    Site Not Available

  • Queen's Hospital

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

    Site Not Available

  • Cheltenham General Hospital

    Cheltenham, England GL53 7AN
    United Kingdom

    Site Not Available

  • Essex County Hospital

    Colchester, England C03 3NB
    United Kingdom

    Site Not Available

  • Walsgrave Hospital

    Coventry, England CV2 2DX
    United Kingdom

    Site Not Available

  • Derbyshire Royal Infirmary

    Derby, England DE1 2QY
    United Kingdom

    Site Not Available

  • Dorset County Hospital

    Dorchester, England DT1 2JY
    United Kingdom

    Site Not Available

  • Russells Hall Hospital

    Dudley, England DY1 2HQ
    United Kingdom

    Site Not Available

  • Gloucestershire Royal Hospital

    Gloucester, England GL1 3NN
    United Kingdom

    Site Not Available

  • Hereford Hospitals NHS Trust

    Hereford, England HR1 2ER
    United Kingdom

    Site Not Available

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England HD3 3EA
    United Kingdom

    Site Not Available

  • Ipswich Hospital

    Ipswich, England IP4 5PD
    United Kingdom

    Site Not Available

  • Airedale General Hospital

    Keighley, England BD20 6TD
    United Kingdom

    Site Not Available

  • Royal Lancaster Infirmary

    Lancaster, England LA1 4RP
    United Kingdom

    Site Not Available

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England LS9 7TF
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, England LE1 5WW
    United Kingdom

    Site Not Available

  • Liverpool Women's Hospital

    Liverpool, England LV8 7SS
    United Kingdom

    Site Not Available

  • Guy's Hospital

    London, England SE1 9RT
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, England W12 OHS
    United Kingdom

    Site Not Available

  • Saint Bartholomew's Hospital

    London, England EC1A 7BE
    United Kingdom

    Site Not Available

  • St. Georges, University of London

    London, England SW17 0QT
    United Kingdom

    Site Not Available

  • University College of London Hospitals

    London, England NW1 2PG
    United Kingdom

    Site Not Available

  • Mid Kent Oncology Centre at Maidstone Hospital

    Maidstone, England ME16 9QQ
    United Kingdom

    Site Not Available

  • Christie Hospital

    Manchester, England M20 4BX
    United Kingdom

    Site Not Available

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England CT9 4AN
    United Kingdom

    Site Not Available

  • Clatterbridge Centre for Oncology

    Merseyside, England CH63 4JY
    United Kingdom

    Site Not Available

  • Northampton General Hospital NHS Trust

    Northampton, England NN1 5BD
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England HA6 2RN
    United Kingdom

    Site Not Available

  • Nottingham City Hospital NHS Trust

    Nottingham, England NG5 1PB
    United Kingdom

    Site Not Available

  • Kings Mill Hospital

    Nottinghamshire, England NG17 4JL
    United Kingdom

    Site Not Available

  • George Eliot Hospital

    Nuneaton, England CV10 7DJ
    United Kingdom

    Site Not Available

  • Whiston Hospital

    Prescot Merseyside, England L35 5DR
    United Kingdom

    Site Not Available

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England PR2 9HT
    United Kingdom

    Site Not Available

  • Alexandra Healthcare NHS

    Redditch, Worcestershire, England B98 7UB
    United Kingdom

    Site Not Available

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England S1O 2SJ
    United Kingdom

    Site Not Available

  • Wexham Park Hospital

    Slough, Berkshire, England SL2 4HL
    United Kingdom

    Site Not Available

  • Royal Marsden - Surrey

    Sutton, England SM2 5PT
    United Kingdom

    Site Not Available

  • Taunton and Somerset Hospital

    Taunton Somerset, England TA1 5DA
    United Kingdom

    Site Not Available

  • South Warwickshire Hospital

    Warwick, Warwickshire, England CV34 5BJ
    United Kingdom

    Site Not Available

  • Southend University Hospital NHS Foundation Trust

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

    Site Not Available

  • Weston General Hospital

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

    Site Not Available

  • Worcester Royal Hospital

    Worcester, England WR5 1DD
    United Kingdom

    Site Not Available

  • Worthing Hospital

    Worthing, England BN11 2DH
    United Kingdom

    Site Not Available

  • Yeovil District Hospital

    Yeovil - Somerset, England BA21 4AT
    United Kingdom

    Site Not Available

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

    Belfast, Northern Ireland BT9 7BL
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland AB25 2ZN
    United Kingdom

    Site Not Available

  • Dumfries & Galloway Royal Infirmary

    Dumfries, Scotland DG1 4AP
    United Kingdom

    Site Not Available

  • Ninewells Hospital

    Dundee, Scotland DD1 9SY
    United Kingdom

    Site Not Available

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland EH4 2XR
    United Kingdom

    Site Not Available

  • Gartnavel General Hospital

    Glasgow, Scotland G12 0YN
    United Kingdom

    Site Not Available

  • Raigmore Hospital

    Inverness, Scotland 1V2 3UJ
    United Kingdom

    Site Not Available

  • Ysbyty Gwynedd

    Bangor, Wales LL57 2PW
    United Kingdom

    Site Not Available

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales CF4 7XL
    United Kingdom

    Site Not Available

  • West Wales General Hospital

    Carmarthen, Wales SA31 2AF
    United Kingdom

    Site Not Available

  • South West Wales Cancer Institute

    Swansea, Wales SA2 8QA
    United Kingdom

    Site Not Available

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