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Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: December 8, 2004   Last Updated: July 8, 2009   History of Changes
Sponsor: NHS Greater Glasgow and Clyde
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098878
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Clinical overall response rate and CA125 response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: March 2004
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098878

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000396778, SCOTTISH-SCOTROC-4, EU-20402
Study First Received: December 8, 2004
Last Updated: July 8, 2009
ClinicalTrials.gov Identifier: NCT00098878     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Digestive System Neoplasms
Ovarian Neoplasms
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin
Ovarian Diseases
Abdominal Neoplasms
Pharmacologic Actions
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009