Safety and efficacy of thalidomide in recurrent epithelial ovarian and peritoneal carcinoma

Objective. Thalidomide is an anti-angiogenesis agent that has shown activity in some solid tumors. We performed a phase I clinical trial to determine the toxicity and potential efficacy of Thalidomide in recurrent epithelial ovarian carcinoma. Methods. Patients with recurrent ovarian cancer were evaluated between 1998 and 2000. Data were evaluated using Kaplan-Meier and logistic regression analyses. Results. 17 heavily pretreated patients with recurrent epithelial ovarian cancer received oral Thalidomide starting at 100 mg/day, with dose escalations of 100 mg/day every 2 weeks, up to 1200 mg/day as tolerated. The median number of courses was four (range: 1-18 courses), and median dose was 200 mg/day (range: 100-600 mg/day). Treatment duration ranged from 2 to 48 months. Common grade 1 or 2 side effects included constipation (76%), neuropathy (71 %), and fatigue (65%) with few grade 3 or 4 events. Three (18%) patients had partial responses, and six (35%) had stabilization of disease after 6 months. After 1 year of treatment, six of the nine patients with an initial partial response (n = 2) or stable disease (n = 4) remained in these response categories. Median time to progression was 10 months. Forty-seven percent of patients had a 50-70% decrease in CA 125 levels. Using logistic regression and repeated measures analyses, CA 125 levels decreased by 62 units/ml per month (p = 0.07). Conclusion. Our Study demonstrates the safety, tolerability, and potential efficacy of Thalidomide in recurrent and refractory epithelial ovarian cancers. Additional clinical trials are warranted. (c) 2006 Elsevier Inc. All rights reserved.