Caelyx (Ca) And Carboplatin (Pa) In Patients With Advanced Ovarian Cancer In Late Relapse (> 6 Months) (AOCLR): A GINECO Phase II Trial

Reviewer: Roberto Santiago, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 18, 2002

Presenter: JM Ferrero
Presenter's Affiliation: GINECO, Paris, France
Type of Session: Poster


  • Previous studies have demonstrated that patients with ovarian cancer who have a time-to-relapse interval > 6 months retain sensitivity to platinum-derivatives
  • Caelyx (Ca, doxil) is a liposomal doxorubicin that has been shown to be as effective as topotecan in ovarian cancer patients in relapse after a platinum-based regimen
  • A previous phase I study by P. Viens determined the safe doses of a regimen consisting of Caelyx (Ca, 30 mg/m2 on day 1) and carboplatin (Pa, 30 minute infusion of AUC 5 mg/ml per minute on day 1) delivered every 4 weeks
  • The GINECO initiated a phase II trial to investigate the efficacy and tolerance of combined Ca and Pa in ovarian cancer patients with late relapse (> 6 months) who were pre-treated with platinum and taxane based chemotherapy.

Materials and Methods

  • The study was an open, non comparative, multicentre, phase II trial
  • Eligibility criteria included recurrent ovarian carcinoma previously treated with one or two platinum and taxane based regimes with a treatment-free interval between last treatment and inclusion of > 6 months,
  • From 04/00 to 03/01, 105 patients were treated with a regimen consisting of Ca, 30 mg/m2 on day 1, and Pa, AUC 5 mg/ml per minute for 30 minutes on day 1, repeated on day 28
  • Response was evaluated every two cycles using WHO criteria for measurable disease and Rustin?s criteria for non-measurable disease and CA-125 > 40IU/ml


  • The median age was 61 years (range 23-79)
  • Histology was serous in 74% with Grade as follows; Grade 1-2, 31%; grade 3, 26%; unknown grade, 43%
  • 54% had measurable disease, and 86% had a CA-125 > 40 IU/ml
  • Previously treated with 1 regimen, 60%; with 2, 40%
  • Patients received a median of 6 cycles (1-10)
  • Hematologic NCI grade 3-4 toxicity included Neutropenia, 51%, Anemia, 12%, Thrombocytopenia, 26%
  • Non-hematological grade 2-3 toxicities included Nausea/vomiting, 32%, alopecia, 12%, Mucositis, 12%, Fatigue, 10%, Palmar-plantar erythrodysesthesia, 10%, Neuropathy, 7%
  • Overall response rate; Measurable disease, 60%; CA-125 assessable, 65%; total, 63%
  • Complete response rate; Measurable disease, 31%; CA-125 assessable, 46%; total, 38%
  • Response was independent of the number of previous chemotherapy regimens
  • Median progression-free survival (months) in responders; Measurable disease, 14.1; CA-125 assessable, 11.2
  • Median progression-free survival (months) in stable disease; Measurable disease, 6.0; CA-125 assessable, 6.1
  • Overall median progression-free survival was 9.4 months

Author's Conclusions

    The combination of Ca and Pa was very active and well tolerated in patients with ovarian cancer who have a time-to-relapse interval > 6 months after prior platinum and taxane based therapy.

Clinical/Scientific Implications

  • High overall and complete response rates (63% and 38%, respectively) were observed
  • Overall median time to progression was 9.4 months and median overall survival has not been reached
  • Main toxicity was moderate hematological toxicity
  • Low rates of alopecia and neuropathy were observed
  • Phase III studies of the regimen tested in this Phase II study are warranted

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