Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
NCT ID: NCT00004876
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
1999-08-31
Brief Summary
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PURPOSE: This randomized 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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Detailed Description
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* Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer.
* Determine the antiangiogenic effect of thalidomide in this patient population.
* Compare the efficacy of carboplatin with or without thalidomide in this patient population.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive carboplatin IV over 1 hour. Treatment continues every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive carboplatin as in arm I. Patients receive thalidomide orally once daily. Thalidomide treatment continues for up to 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last course of carboplatin.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
thalidomide
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed stage IC-IV ovarian epithelial cancer
* Post-menopausal OR
* Prior bilateral salpingo-oophorectomy and/or total abdominal hysterectomy
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other concurrent invasive malignancies
* Not pregnant
* No diabetes mellitus
* No chronic neurological disease causing peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No other concurrent cytotoxic agents
Endocrine therapy:
* Not specified
Radiotherapy:
* Concurrent local radiotherapy for treatment of secondary disease sites allowed
Surgery:
* See Disease Characteristics
18 Years
FEMALE
No
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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T.S. Ganesan, MD
Role: STUDY_CHAIR
Oxford University Hospitals NHS Trust
Locations
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Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Countries
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References
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Muthuramalingam SR, Braybrooke JP, Blann AD, Madhusudan S, Wilner S, Jenkins A, Han C, Kaur K, Perren T, Ganesan TS. A prospective randomised phase II trial of thalidomide with carboplatin compared with carboplatin alone as a first-line therapy in women with ovarian cancer, with evaluation of potential surrogate markers of angiogenesis. Eur J Gynaecol Oncol. 2011;32(3):253-8.
Muthuramalingam SR, Braybrooke JP, Madhusudan S, et al.: A randomised phase two study of carboplatin versus carboplatin and thalidomide in patients with ovarian cancer, with evaluation of potential surrogate markers of angiogenesis. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-303, 86, 2004.
Other Identifiers
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ICRF-96.084
Identifier Type: -
Identifier Source: secondary_id
EU-99018
Identifier Type: -
Identifier Source: secondary_id
CDR0000067536
Identifier Type: -
Identifier Source: org_study_id
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