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A phase II study of pegylated liposomal doxorubicin oxaliplatin and cyclophosphamide as second-line treatment in relapsed ovarian carcinoma
  1. M. R. Valerio*,
  2. P. Tagliaferri,
  3. F. Raspagliesi,
  4. F. Fulfaro*,
  5. G. Badalamenti*,
  6. C. Arcara*,
  7. G. Cicero*,
  8. A. Russo*,
  9. S. Venuta,
  10. G. Guarneri§ and
  11. N. Gebbia*
  1. * Operative Unit of Medical Oncology, Department of Oncology, Università degli Studi di Palermo, Palermo, Italy
  2. Operative Unit of Medical Oncology, Università degli Studi di Catanzaro, Catanzaro, Italy
  3. National Cancer Institute, Milan, Italy
  4. § IMI, Università degli Studi di Palermo, Palermo, Italy
  1. Address correspondence and reprint requests to: Nicola Gebbia, MD, Operative Unit of Medical Oncology, Department of Oncology, Università degli Studi di Palermo, Via del Vespro 127, 90127 Palermo, Italy. Email: chemotherapy{at}


We carried out a phase II nonrandomized study to examine the level of activity of oxaliplatin, pegylated liposomal doxorubicin, and cyclophosphamide in a patient population with relapsed ovarian cancer pretreated with platinum derivatives and paclitaxel. Patients received oxaliplatin (85 mg/m2), pegylated liposomal doxorubicin (30 mg/m2), and cyclophosphamide (750 mg/m2). A total of 49 patients (39 assessable for toxicity and response) were enrolled in this trial. Neutropenia grade 3 was observed in six patients (15%) and anemia grade 3 in one patient (0.2%). Fatigue grade 1–2 occurred in 26 patients (66%), nausea/vomiting grade 1 in 23 patients (58%), and alopecia grade 1–2 in 19 patients (48%). Twenty-one (53%) patients experienced grade 1–2 peripheral neuropathy. The overall response rate was 46% (95% CI 23.6–68.7). Median progression-free survival was 28 weeks (range 12–52 weeks) and median survival was 45 weeks (range 26–136+ weeks). The mean duration of response was 34 weeks (range 16–52 weeks). In platinum-resistant and -refractory ovarian cancer patients, the overall response rate was 37% (CI 95% 14.4–60.8) with a progression-free survival of 28 weeks (range 12–52 weeks) and a median survival of 42 weeks (range 28–84 weeks). This combination chemotherapy is generally well tolerated and is an active second-line regimen against ovarian cancer.

  • chemotherapy
  • liposomal doxorubicin
  • ovarian cancer
  • oxaliplatin
  • second-line therapy

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