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A Study of the VWOG

This study investigates the combination of PLD and GEM in a 4-week schedule for recurrent platinum resistant ovarian cancer. Phase I results show dose level 2b (PLD 30 mg/m² on day 1, GEM 800 mg/m² on day 1, 8, 15 q 4 weeks) as the recommended schedule. Phase II results demonstrate an interesting response rate (30%), clinical benefit (70%) and progression-free survival (9 months). The regimen is well-tolerated compared to other treatment options.

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A Study of the VWOG

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  1. PHASE I/II STUDY OF PEGYLATED LIPOSOMAL DOXORUCIN (PLD) AND GEMCITABINE (GEM) IN RECURRENT PLATIN RESISTANT OVARIAN CANCER (OC). A Study of the VWOG

  2. Caelyx and Gemcitabine in recurrentovariancancer Rationale • Pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) are 2 active drugs in recurrent ovarian cancer. • Few trials have investigated the combination of these 2 drugs in this setting. • Despite the fact that PLD is usually given in a 4-week schedule, most Phase II studies in ovarian and breast cancer have used a 3-week regimen with this combination. • Given encouraging response rates on other diseases and the lower incidence of PPE and bone marrow toxicity with a 4 weeks schedule of PLD, the present study is testing the combination of PLD and GEM in a 4-week schedule.

  3. Caelyx and Gemcitabine in recurrentovariancancer PHASE I (n=17)

  4. Caelyx and Gemcitabine in recurrentovariancancer PHASE I (n=17) (reported ESGO 2007) • First cohort 1a to 1d will be accrued up to MTD followed by 2a to 2d up to the MTD. • The dose limiting toxicity was Grade 4 trombocytopenia. • Dose level 2b was the recommended schedule: • PLD 30 mg/m² on day 1 • GEM 800 mg/m² on day 1,8, 15 q 4 weeks.

  5. Caelyx and Gemcitabine in recurrentovariancancer PHASE II (n=24) Inclusion Criteria • Histological diagnosis of epithelial ovarian, fallopian tube or peritoneal carcinoma. • Measurabledisease (RECIST) • Patient has received at least one or two prior platin-based chemotherapy regimens for advanced or metastatic disease, and a treatment-free interval of less than 6 months after the last platin-based chemotherapy. • No prior Anthracyclines or Gemcitabinetherapy. • Second-line retreatment with (taxanes)/platin was allowed. Second-line therapy with other drugs was not allowed. • Left ventricular ejection fraction  50 % as determined by MUGA (isotopic methods) or ultrasound.

  6. Caelyx and Gemcitabine in recurrentovariancancer PHASE II (n=24) In total 109 courses were administered

  7. Caelyx and Gemcitabine in recurrentovariancancer Efficacy Phase II (n=20)

  8. Caelyx and Gemcitabine in recurrentovariancancer Efficacy Phase II (n=20)

  9. Caelyx and Gemcitabine in recurrentovariancancer Conclusion Caelyx and Gemzar in a 4 weekly regimen resulted in platin resistant recurrent ovarian cancer compared with other treatment options: acceptable toxicity interestingresponse rate (30%), clinical benefit (70%) and PFS (9 monts). .

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