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

Share article


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

Background

  • 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

Results

  • 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

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.


News
Optimal Dose Suggested for Dasatinib in Ovarian Cancer

Nov 21, 2012 - A phase I trial of dasatinib combined with paclitaxel and carboplatin has determined the optimal dose of dasatinib and suggested some efficacy in women with advanced or recurrent ovarian cancer, according to research published in the Oct. 1 issue of Clinical Cancer Research.



I Wish You Knew

How cancer patients have changed my life

View More



Blogs and Web Chats

OncoLink Blogs give our readers a chance to react to and comment on key cancer news topics and provides a forum for OncoLink Experts and readers to share opinions and learn from each other.




OncoLink OncoPilot

Facing a new cancer diagnosis or changing the course of your current treatment? Let our cancer nurses help you through!

Learn More