Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer

A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumor. PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.

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.

stage IV ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer

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

Muthuramalingam SR, Braybrooke JP, Blann AD, Madhusudan S, Wilner S, Jenkins A, Han C, Kaur K, Perren T, Ganesan TS. A prospective randomised phase II trial of thalidomide with carboplatin compared with carboplatin alone as a first-line therapy in women with ovarian cancer, with evaluation of potential surrogate markers of angiogenesis. Eur J Gynaecol Oncol. 2011;32(3):253-8.

Muthuramalingam SR, Braybrooke JP, Madhusudan S, et al.: A randomised phase two study of carboplatin versus carboplatin and thalidomide in patients with ovarian cancer, with evaluation of potential surrogate markers of angiogenesis. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-303, 86, 2004.