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
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.
- 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.
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