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ISRCTN
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ISRCTN12694440
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ClinicalTrials.gov identifier
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NCT00004876
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Public title
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A randomised study comparing carboplatin and carboplatin with thalidomide in patients with Stage Ic-IV Ovarian Cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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96.084
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Study hypothesis
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Drugs used in chemotherapy use different ways to stop tumour cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumour.
This randomised phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ovarian cancer
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Participants - inclusion criteria
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1. Histologically confirmed epithelial ovarian cancer
2. Post-menopausal or if pre-menopausal, patients must have had a bilateral salpingo-oophorectomy and/or a total abdominal hysterectomy
3. Stage Ic-IV ovarian cancer
4. Aged over 18 years
5. World Health Organisation (WHO) performance status 0, 1 or 2
6. Written informed consent
7. No previous carboplatin/cisplatin treatment for ovarian cancer
8. No other current invasive malignancy
9. Neither pregnant or with the ability to become pregnant
10. No chronic neurological disease causing peripheral neuropathy
11. No diabetes mellitus
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/08/1999
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Anticipated end date
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31/12/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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30
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Interventions
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Patients entering the trial will be randomised to receive carboplatin (every 4 weeks for a maximum of six cycles) only or carboplatin with thalidomide (for 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last cycle of chemotherapy).
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Primary outcome measure(s)
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1. Safety
2. Response
3. Markers of angiogenesis
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Cancer Research UK (CRUK) (UK)
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Trial website
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Publications
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Contact name
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Dr
TS
Ganesan
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Address
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Oxford Radcliffe Hospital
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City/town
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Oxford
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Zip/Postcode
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0X3 9DU
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Country
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United Kingdom
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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19/08/2002
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Last edited
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22/05/2008
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Date ISRCTN assigned
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19/08/2002
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