1 / 4

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.

duscha
Download Presentation

GCIG Belgrade Oct 2009 Ros Glasspool

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related