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Phase II multicenter open-label study of carboplatin and pegylated liposomal doxorubicin in uterine and cervical malignancies
  1. L. H. LÊ*,
  3. L. ELIT,
  5. G. C.E. STUART,
  6. T. LE,
  7. U. LEE#,
  8. A. RODGERS††,
  9. G. R. POND*,
  10. H. HU* and
  11. A. M. OZA*
  1. *Princess Margaret Hospital, Toronto, ON, Canada
  2. †Vancouver Cancer Centre, Vancouver, BC, Canada
  3. ‡Hamilton Regional Cancer, Hamilton, ON, Canada
  4. §Centre hospitalier de l'Université de Montréal – Hôpital Nôtre-Dame, Montréal, QC, Canada
  5. ∥Tom Baker Cancer Centre, Calgary, AB, Canada
  6. ¶Ottawa Regional Cancer Centre, Ottawa, ON, Canada
  7. #Fraser Valley Cancer Centre, Surrey, BC, Canada
  8. ††Schering Canada Inc., Montréal, QC, Canada
  1. Address correspondence and reprint requests to: Dr Amit M. Oza, MD, Princess Margaret Hospital, Room 5-206, 610 University Avenue, Toronto, ON, Canada M5G 2M9. Email: amit.oza{at}


The results of a multicenter phase II study investigating carboplatin and pegylated liposomal doxorubicin (PLD) in patients with recurrent/metastatic uterine and cervical malignancies (UCM) are presented here. Fifty-three subjects with measurable, untreated, advanced UCM were enrolled. Fifty-one were evaluable for response. Prior combined-modality treatment was permitted if a component of primary therapy. Patients received carboplatin AUC = 5 with PLD 35 mg/m2 intravenously once every 4 weeks. Overall response rate was 33% (35% stable disease). Overall survival (OS) at six months was 86% (95% CI 76%–96%). Six-month progression-free survival (PFS) was 43% (95% CI 30%–57%). Median PFS was 22.9 weeks (range 16.0–35.3) and median OS was 49.1 weeks (range 41.4–75.1). The most frequent grade 3-4 nonhematological adverse events were: abdominal pain (n = 7), fatigue (4), vomiting (4), nausea (3), and shortness of breath (3). There was 1 report of grade 3 hand-foot syndrome and none of grade 4. Twelve patients had first infusion reactions with only 1 discontinuing treatment. Grade 3-4 neutropenia occurred in 26/230 cycles (11.3%). There were no treatment-related deaths. The combination of carboplatin and PLD is well tolerated with sufficient activity to justify additional evaluation in clinical trials and might be suited to the addition of a taxane.

  • cervical cancer
  • uterine cancer
  • malignant mixed Müllerian tumors
  • pegylated liposomal doxorubicin
  • carboplatin

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