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Objective A prospective phase II study was conducted to evaluate the efficacy and toxicity of oxaliplatin plus 5-fluoruracil (5-FU) and high-dose leucovorin (LV) (FOLFOX-4) in patients with platinum-resistant, taxane-pretreated recurrent ovarian cancer. Patients and methods Thirty-eight patients, with a median age of 58 years (range 33–77), were treated with oxaliplatin 85 mg m −2 as a 2-h infusion on day 1, LV 200 mg m −2 day −1 as a 2-h infusion followed by bolus 5-FU 400 mg m −2 day −1 and a 22-h infusion of 5-FU 600 mg m −2 day −1 for 2 consecutive days. Treatment was repeated every 3 weeks. Patients were evaluated for response every two cycles. Results The vast majority of patients had performance status 0 or 1 and 76.3% had ≥ 2 metastatic sites. A median number of four cycles per patient (range, 1–8) were administered. Based on an intention-to-treat analysis, 3 patients (7.9%) achieved a complete response (CR) and 8 (21.1%) achieved a partial response (PR), for an overall response rate of 29%. Another 29% of patients had stable disease (SD). The median relapse-free survival was 5.2 months (range 2.5–17), the median time to tumor progression was 4.8 months (range 0.6–19), and the median overall survival was 10.1 months (range 0.2–36). Toxicity was mild to moderate. Grade 3/4 neutropenia and thrombocytopenia occurred in 29% and 21.1% of patients, respectively. Febrile neutropenia was encountered in 3 patients (7.9%), who were successfully treated. Grade 3/4 neurotoxicity developed in 15.8% of patients; neurotoxicity gradually declined after treatment discontinuation. Alopecia, nausea–vomiting, diarrhea, mucositis, and asthenia were not a serious problem. There were no treatment-related deaths. Conclusion The combination of oxaliplatin and 5-FU/LV (FOLFOX-4) appears to be an effective regimen with a good toxicity profile for the treatment of platinum-resistant, taxane-pretreated ovarian cancer.

Objectives The purpose of this study was to evaluate the activity and toxicity of carboplatin and paclitaxel combination in advanced or recurrent endometrial carcinoma. Methods Forty-seven eligible patients with measurable advanced or recurrent endometrial carcinoma were treated with carboplatin [area under the curve (AUC) 5] and paclitaxel 175 mg/m(2) every 3 weeks for 6-9 cycles or until disease progression or unacceptable toxicity. Results There were 10 complete responses (CRs) (21%) and 19 partial responses (PRs) (41%) for an overall response rate (RR) of 62% (29 patients) (95% confidence interval [CI], 47-76%). The median progression-free survival (PFS) was 15 months (95% CI, 7.3-22.7 months) and the median overall survival (OS) was 25 months (95% CI, 19.0-31.0 months). No difference was found in RR and OS in patients with primary advanced disease and those with recurrent tumors. Similarly, no difference was found in PFS and OS for patients with serous/clear tumors and those with endometrioid tumors. Toxicity was generally mild except for myelotoxicity. Neutropenia grade 3/4 was recorded in 36% of patients and 6% experienced febrile neutropenia. One patient each developed grade 4 thrombocytopenia and anemia. Grade 3 sensory neuropathy was recorded in 6% of patients. Conclusion The combination of carboplatin and paclitaxel appears to have activity in advanced or recurrent endometrial carcinoma with an acceptable toxicity profile.

Objectives. This phase II study conducted to investigate the efficacy and toxicity of the combination of gemcitabine (GEM) and pegylated liposomal doxorubicin (LDOX) alternating with cisplatin (CDDP) and cyclophosphamide (CTX) in platinum-resistant/refractory, paclitaxel pretreated epithelial ovarian cancer (EOC). Patients and methods. Forty-eight patients with CDDP-resistant/refractory and paclitaxel pretreated patients were treated with 8 cycles of GEM 800 mg/m 2 days 1 and 8 and LDOX 30 mg/m 2 day 1, alternating with CDDP 60 mg/m 2 and CTX 600 mg/m 2 every 3 weeks. Results. Objective responses were observed in 37.5% of patients (4 complete and 11 partial responses) with measurable disease ( n =40). CA125 response occurred in 30 (71.4%) of patients with elevated CA125 ( n =42). After a median follow-up of 23 months, the median progression-free survival (PFS) was 6.9 months (95% confidence interval, CI: 5.2–8.5), while the median overall survival (OS) was 18.2 months (95% CI: 12.7–23.6). A progression-free interval (PFI) of 0–3 months was associated with lower objective responses (10% versus 46.6%, p =0.06). Chemotherapy was well tolerated. The most frequent toxicities were myelosuppression, neurotoxicity, nephrotoxicity, nausea/vomiting, fatigue and palmar-plantar erythrodysesthesia (PPE). Overall 31 (65%) patients received G-CSF and 13 (27%) antibiotics because of neutropenia and/or febrile neutropenia. Conclusion. This alternating combination chemotherapy is feasible for patients with platinum-resistant EOC and is associated with encouraging outcomes and a favorable toxicity profile.