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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


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
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