Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

Phase II Trial of Thalidomide in Patients With Ovarian Cancer

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.

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.

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