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

August 6, 2013 updated by: NHS Greater Glasgow and Clyde

SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Hornsby, New South Wales, Australia, 2077
        • Sydney Heamatology and Oncology Clinics
      • Lismore, New South Wales, Australia, 2480
        • Lismore Base Hospital
      • Randwick, New South Wales, Australia, 2031
        • Institute of Oncology at Prince of Wales Hospital
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australia, 2050
        • Sydney Cancer Centre at Royal Prince Alfred Hospital
      • Tamworth, New South Wales, Australia, 2340
        • Tamworth Base Hospital
      • Taree, New South Wales, Australia, 2430
        • Manning Base Hospital
      • Waratah, New South Wales, Australia, 2298
        • Newcastle Mater Misericordiae Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Institute for Cancer Research at Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Douglas, Queensland, Australia, 4814
        • Townsville Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Oncology and Haematology Services
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Carlton, Victoria, Australia, 3053
        • Royal Women's Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Center - Clayton Campus
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Mercy Hospital for Women
      • Wodonga, Victoria, Australia, 3690
        • Murray Valley Private Hospital and Cancer Treatment Centre
  • New Zealand
      • Auckland, New Zealand, 1
        • Auckland City Hospital
      • Christchurch, New Zealand, 1
        • Christchurch Hospital
      • Hamilton, New Zealand, 2020
        • Waikato Hospital
      • Wellington, New Zealand, 6039
        • Wellington Cancer Centre
  • United Kingdom
    • England
      • Barrow in Furness, England, United Kingdom, LA14 4LF
        • Furness General Hospital
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Birmingham, England, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Blackburn, England, United Kingdom, BB2 3HH
        • Royal Blackburn Hospital
      • Blackpool, England, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Bradford, England, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Brighton, England, United Kingdom, BN2 5BE
        • Sussex Cancer Centre at Royal Sussex County Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Broomfield, England, United Kingdom, CM1 7ET
        • Broomfield Hospital
      • Burton-upon-Trent, England, United Kingdom, DE13 0RB
        • Queen's Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Colchester, England, United Kingdom, C03 3NB
        • Essex County Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Dorchester, England, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Dudley, England, United Kingdom, DY1 2HQ
        • Russells Hall Hospital
      • Gloucester, England, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
      • Hereford, England, United Kingdom, HR1 2ER
        • Hereford Hospitals NHS Trust
      • Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Keighley, England, United Kingdom, BD20 6TD
        • Airedale General Hospital
      • Lancaster, England, United Kingdom, LA1 4RP
        • Royal Lancaster Infirmary
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Liverpool, England, United Kingdom, LV8 7SS
        • Liverpool Women's Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, W12 OHS
        • Hammersmith Hospital
      • London, England, United Kingdom, NW1 2PG
        • University College of London Hospitals
      • London, England, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, England, United Kingdom, SW17 0QT
        • St. Georges, University of London
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Mid Kent Oncology Centre at Maidstone Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Margate, England, United Kingdom, CT9 4AN
        • Queen Elizabeth the Queen Mother Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre For Oncology
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Nottinghamshire, England, United Kingdom, NG17 4JL
        • Kings Mill Hospital
      • Nuneaton, England, United Kingdom, CV10 7DJ
        • George Eliot Hospital
      • Prescot Merseyside, England, United Kingdom, L35 5DR
        • Whiston Hospital
      • Preston, England, United Kingdom, PR2 9HT
        • Rosemere Cancer Centre at Royal Preston Hospital
      • Redditch, Worcestershire, England, United Kingdom, B98 7UB
        • Alexandra Healthcare NHS
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Slough, Berkshire, England, United Kingdom, SL2 4HL
        • Wexham Park Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey
      • Taunton Somerset, England, United Kingdom, TA1 5DA
        • Taunton and Somerset Hospital
      • Warwick, Warwickshire, England, United Kingdom, CV34 5BJ
        • South Warwickshire Hospital
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
      • Weston-super-Mare, England, United Kingdom, BS23 4TQ
        • Weston General Hospital
      • Worcester, England, United Kingdom, WR5 1DD
        • Worcester Royal Hospital
      • Worthing, England, United Kingdom, BN11 2DH
        • Worthing Hospital
      • Yeovil - Somerset, England, United Kingdom, BA21 4AT
        • Yeovil District Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7BL
        • Centre for Cancer Research and Cell Biology at Queen's University Belfast
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Dumfries, Scotland, United Kingdom, DG1 4AP
        • Dumfries & Galloway Royal Infirmary
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, Scotland, United Kingdom, EH4 2XR
        • Edinburgh Cancer Centre at Western General Hospital
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Gartnavel General Hospital
      • Inverness, Scotland, United Kingdom, 1V2 3UJ
        • Raigmore Hospital
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
        • Ysbyty Gwynedd
      • Cardiff, Wales, United Kingdom, CF4 7XL
        • Velindre Cancer Center at Velindre Hospital
      • Carmarthen, Wales, United Kingdom, SA31 2AF
        • West Wales General Hospital
      • Swansea, Wales, United Kingdom, SA2 8QA
        • South West Wales Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival
Quality of life
Clinical overall response rate and CA125 response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • Study Chair: Stanley B. Kaye, MD, FRCP, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 8, 2004

First Submitted That Met QC Criteria

December 8, 2004

First Posted (Estimate)

December 9, 2004

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOTTISH-SCOTROC-4
  • CDR0000396778 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20402
  • ISRCTN47645935 (Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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