A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer
18 Years
N/A
Female
Ovarian Cancer
Trial Information
A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Safety
Safety Issue:
Yes
Principal Investigator
T.S. Ganesan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Oxford Radcliffe Hospital
Authority:
Unspecified
Study ID:
CDR0000067536
NCT ID:
NCT00004876
Start Date:
August 1999
Completion Date:
Related Keywords:
- Ovarian Cancer
- stage IV ovarian epithelial cancer
- stage IC ovarian epithelial cancer
- stage IIA ovarian epithelial cancer
- stage IIB ovarian epithelial cancer
- stage IIC ovarian epithelial cancer
- stage IIIA ovarian epithelial cancer
- stage IIIB ovarian epithelial cancer
- stage IIIC ovarian epithelial cancer
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
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