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GCIG Belgrade Oct 2009 Ros Glasspool

GCIG Belgrade Oct 2009 Ros Glasspool. A Randomised Phase III Trial of Weekly Carboplatin and Paclitaxel versus Pegylated Liposomal Doxorubicin In Recurrent, Platinum Resistant, Ovarian Cancer. DDPC- PREOC. Regimen. RR %. PFS months. OS months. Ref. P90, C AUC4 day 1 and 8 q21. 43. 6.75.

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GCIG Belgrade Oct 2009 Ros Glasspool

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  1. GCIG Belgrade Oct 2009 Ros Glasspool A Randomised Phase III Trial of Weekly Carboplatin and Paclitaxel versus Pegylated Liposomal Doxorubicin In Recurrent, Platinum Resistant, Ovarian Cancer DDPC- PREOC

  2. Regimen • RR % • PFS months • OS months • Ref • P90, C AUC4 day 1 and 8 q21 • 43 • 6.75 • 8 • Cadron 2007 • P90, C AUC4 Day 1, 8, 15 q28 x2 • 53 • 10 • 13 • Van der Burg 2004 • P80, C AUC 2 Day 1, 8, 15 q28 • 37.5 • 3.2 • Havrilesky 2003 • P70, C AUC 3 Day 1, 8, 15 q 28 • 60 • 7.9 • 13.3 • Sharma 2009 • PLDH • 12.3 • 2.1 • 13.3 • Gordon 2001 • PLDH • TFI <12 m • 16 • 3.7 • 12.9 • Ferrandina 2008 • PLDH • 8.3 • 3.1 • 13.5 • Mutch 2007 Rationale for Trial • High RR and long PFS in phase II studies and retrospective series of dose dense/ fractionated Paclitaxel/Carboplatin schedules • Well tolerated • No randomised trials

  3. Carboplatin (AUC 3) and paclitaxel (80 mg/m2) for 3 weeks out of 4 for 6 cycles RANDOMISE 250 patients with platinum resistant disease Pegylated Liposomal Doxorubicin (40 mg/m2) every 4 weeks for 6 cycles Trial Design Primary Endpoint: PFS Secondary Endpoints: Overall Survival Quality of Life Health Economic Analysis Response Rate Toxicity/Hypersensitivity Dose Intensity Post progression therapy

  4. Trial Status • Outline proposal submitted to the NIHR Health Technology Assessment (HTA) programme in July and decision expected Oct 2009.

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