A Randomised Phase III Trial of Weekly

Carboplatin and Paclitaxel versus Pegylated

Liposomal Doxorubicin In Recurrent, Platinum

Resistant, Ovarian Cancer

GCIG Belgrade Oct 2009

Ros Glasspool

DDPC- PREOC

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

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 2Day 1, 8, 15 q28

37.5 3.2   Havrilesky2003

P70, C AUC 3Day 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

Trial Design

Carboplatin (AUC 3) and paclitaxel (80 mg/m2) for 3 weeks out of 4 for 6 cycles

Pegylated Liposomal Doxorubicin (40 mg/m2) every 4 weeks for 6 cycles

RANDOMISE

250 patients with platinum resistant disease

Primary Endpoint: PFS

Secondary Endpoints: Overall SurvivalQuality of Life Health Economic AnalysisResponse RateToxicity/HypersensitivityDose Intensity Post progression therapy

Trial Status

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