Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00016224


Primary Contact:

Study Chair
David R. Spriggs, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.