NCT01388621

Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer

PROVE A Randomized Phase II Trial of Standard Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian cancer. It is expected that the progression free survival rate at 12 months is improved by the targeted regimen.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	Panitumumab 6 mg/kg/BW d1 + 15 q4w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.
DRUG	pegylated liposomal doxorubicin (PLD)	pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
DRUG	Carboplatin	Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
DRUG	Gemcitabine	gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
DRUG	Carboplatin	Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
DRUG	Panitumumab	Panitumumab 9 mg/kg/BW d1 q3w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-07-01
• Completion: 2015-07-01
• First posted: 2011-07-06
• Last updated: 2013-08-20

Locations

18 sites across 1 country: Germany