© 2005 European Society for Medical Oncology
A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients
1 Institut Paoli-Calmettes, UMR 599, Université de la Méditerranée, Marseille; 2 Centre Paul Strauss, Strasbourg; 3 CAC, Le Kremlin-Bicêtre; 4 Hôpital Bretonneau, Tours; 5 Fondation Hôpital Saint Joseph, Paris; 6 Hôpital St Louis, Paris; 7 Centre Paul Papin, Angers; 8 Hôpital Tenon, Paris, France; 9 University Hospital, Gent, Belgium; 10 Institut Curie, Paris, France
* Correspondence to: Dr. A. Yovine, CAC, 18 rue Pasteur, 94278 Le Kremlin-Bicêtre, France. Tel: +33-1-45-15-40-85; Fax: +33-1-45-15-40-45; E-mail: a.yovine{at}caconcology.com
Purpose: A multicentric, phase II study to evaluate the efficacy and safety of the combination paclitaxel and oxaliplatin in patients with platinum-sensitive recurrent ovarian cancer.
Patients and methods: Patients received 175 mg/m2 paclitaxel (over 3 h) followed by 130 mg/m2 oxaliplatin (over 2 h) every 21 days for up to nine cycles without hydration or primary granulocyte colony-stimulating factor prophylaxis. Patients had to have an Eastern Cooperative Oncology Group performance status of 0–2 and to have received no more than one prior cisplatin- and/or carboplatin-containing chemotherapy regimen with a platinum-progression-free interval 
6 months.
Results: Of the 105 patients enrolled and treated, 98 were eligible. An overall response rate of 81% (79 of 98 patients) (95% confidence interval 71% to 88%) was observed according to RECIST criteria (third party reviewed), and 88% (86 of 98) when this was complemented with CA-125 response. With a median follow up of 43.6 months (range 30.2–64.2) the median progression-free survival was 10.2 months (range 0.3–21.4) and the overall survival 32.4 months. Seven hundred and eight cycles were administered (median seven per patient; range one to nine). A total of 67% of patients experienced National Cancer Institute Common Toxicity Criteria grade 3–4 neutropenia, including 8% with concomitant febrile episode, without treatment-related deaths. Ninety-three per cent of patients experienced neuropathy of grade 1 or more, including 25% with cumulative reversible peripheral neuropathy of grade 3–4. Oxaliplatin doses were reduced in 30 patients due to neurotoxicity.
Conclusions: The oxaliplatin/paclitaxel combination can be administered in an outpatient setting every 3 weeks without specific measures. The high level of activity and its duration observed warrants further evaluation of this combination in pretreated platinum-sensitive advanced ovarian cancer patients.
Key words: ovarian cancer, oxaliplatin, paclitaxel, phase II, platinum-sensitive
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