Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study.

Objective: A phase II study was conducted to determine the efficacy of oxaliplatin therapy in patients with advanced or recurrent endometrial cancer who had received one prior platinum therapy.

Methods: Eligible patients were to have measurable disease and one prior chemotherapy regimen which could include cisplatin or carboplatin. Oxaliplatin 130 mg/m2 was administered intravenously over 2 h. This treatment was repeated every 21 days until progression of disease or adverse effects prohibited further therapy.

Results: Fifty-four patients were entered on study, of which 52 were eligible and 50 had had prior platinum therapy. The overall response rate was 13.5%, with three patients (5.8%) achieving a complete response and four patients (7.7%) achieving a partial response. Median duration of response was 10.9+ (range: 4.1-50.3+) months. Stable disease was reported in 15 (28.8%) patients, with an associated median duration of 5.4 (range: 2.2-19.6) months. Drug-related toxicities consisted of anemia, nausea and vomiting, and neurotoxicity.

Conclusions: Oxaliplatin at the dose and schedule employed has limited activity in patients with advanced or recurrent endometrial carcinoma who have had previous platinum therapy.