A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer
carboplatin
+ thalidomide
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location