Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Thalidomide in Patients With Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer