Ovarian Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer
Brief summary
RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.
Detailed description
OBJECTIVES: * Determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide. * Evaluate the quality of life of patients treated with this regimen. OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 4 weeks. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.
Interventions
DRUGthalidomide
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial carcinoma * Platinum-refractory or resistant disease * At least 1 prior non-platinum chemotherapy agent required * Prior bilateral salpingo-oophorectomy and hysterectomy required * Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3 PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * More than 3 months Hematopoietic: * Not specified Hepatic: * Bilirubin normal * AST no greater than 2.5 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 50 mL/min Other: * No other prior malignancy except non-melanoma skin cancer unless curatively treated with no evidence of disease within the past 5 years and at low risk for recurrence * No other clinical circumstances that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy and recovered * No prior thalidomide Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior cytotoxic therapy and recovered Endocrine therapy: * At least 4 weeks since prior hormonal therapy and recovered Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery
Countries
United States
Outcome results
None listed