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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098878
• Other study ID #: SCOTTISH-SCOTROC-4
• Secondary ID: CDR0000396778EU-
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2004
• Last updated: August 6, 2013
• Start date: March 2004
• Est. completion date: July 2010

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• carboplatin

Locations

Country	Name	City	State
Australia	Ballarat Oncology and Haematology Services	Ballarat	Victoria
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Royal Women's Hospital	Carlton	Victoria
Australia	Monash Medical Center - Clayton Campus	Clayton	Victoria
Australia	Townsville Hospital	Douglas	Queensland
Australia	Frankston Hospital	Frankston	Victoria
Australia	Mercy Hospital for Women	Heidelberg	Victoria
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Sydney Heamatology and Oncology Clinics	Hornsby	New South Wales
Australia	Lismore Base Hospital	Lismore	New South Wales
Australia	Institute of Oncology at Prince of Wales Hospital	Randwick	New South Wales
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Tamworth Base Hospital	Tamworth	New South Wales
Australia	Manning Base Hospital	Taree	New South Wales
Australia	Newcastle Mater Misericordiae Hospital	Waratah	New South Wales
Australia	Westmead Institute for Cancer Research at Westmead Hospital	Wentworthville	New South Wales
Australia	Murray Valley Private Hospital and Cancer Treatment Centre	Wodonga	Victoria
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Cancer Centre	Wellington
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	Furness General Hospital	Barrow in Furness	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Centre for Cancer Research and Cell Biology at Queen's University Belfast	Belfast	Northern Ireland
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	Royal Blackburn Hospital	Blackburn	England
United Kingdom	Blackpool Victoria Hospital	Blackpool	England
United Kingdom	Bradford Royal Infirmary	Bradford	England
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Broomfield Hospital	Broomfield	England
United Kingdom	Queen's Hospital	Burton-upon-Trent	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	West Wales General Hospital	Carmarthen	Wales
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Dumfries & Galloway Royal Infirmary	Dumfries	Scotland
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Gartnavel General Hospital	Glasgow	Scotland
United Kingdom	Gloucestershire Royal Hospital	Gloucester	England
United Kingdom	Hereford Hospitals NHS Trust	Hereford	England
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Airedale General Hospital	Keighley	England
United Kingdom	Royal Lancaster Infirmary	Lancaster	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Liverpool Women's Hospital	Liverpool	England
United Kingdom	Guy's Hospital	London	England
United Kingdom	Hammersmith Hospital	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. Georges, University of London	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Mid Kent Oncology Centre at Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Queen Elizabeth The Queen Mother Hospital	Margate	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	Northampton General Hospital NHS Trust	Northampton	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Kings Mill Hospital	Nottinghamshire	England
United Kingdom	George Eliot Hospital	Nuneaton	England
United Kingdom	Whiston Hospital	Prescot Merseyside	England
United Kingdom	Rosemere Cancer Centre at Royal Preston Hospital	Preston	England
United Kingdom	Alexandra Healthcare NHS	Redditch, Worcestershire	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	South West Wales Cancer Institute	Swansea	Wales
United Kingdom	Taunton and Somerset Hospital	Taunton Somerset	England
United Kingdom	South Warwickshire Hospital	Warwick, Warwickshire	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England
United Kingdom	Weston General Hospital	Weston-super-Mare	England
United Kingdom	Worcester Royal Hospital	Worcester	England
United Kingdom	Worthing Hospital	Worthing	England
United Kingdom	Yeovil District Hospital	Yeovil - Somerset	England

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Countries where clinical trial is conducted

Australia,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Secondary	Toxicity			Yes
Secondary	Quality of life			No
Secondary	Clinical overall response rate and CA125 response			No
Secondary	Overall survival			No