Panitumumab and Pegylated Liposomal Doxorubicin in Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-Type

Abstract

INTERVENTION: Trade Name: Vectibix Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Panitumumab CAS Number: 339177‐26‐3 Other descriptive name: Antineoplastic Concentration unit: mg/ml milligram(s)/millilitre Trade Name: Caelyx Product Name: Calyx Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Doxorubicin CAS Number: 23214‐92‐8 Concentration unit: mg/ml milligram(s)/millilitre CONDITION: Platinum‐Resistant Epithelial Ovarian Cancer with KRAS Wild‐type ; MedDRA version: 9.1 Level: LLT Classification code 10033128 Term: Ovarian cancer PRIMARY OUTCOME: Main Objective: To investigate response rate in platinum‐resistant, ovarian cancer patients without KRAS mutations (KRAS wild‐type) treated with pegylated liposomal doxorubicin supplemented by biological treatment with panitumumab.; Primary end point(s): Response rates (based on GCIG modified CA‐125 criteria’s (30;31)); RECIST criteria will not be used in this protocol.; Secondary Objective: To investigate the PFS and OS in ovarian cancer patients treated with pegylated liposomal doxorubicin and panitumumab. Furthermore, to investigate the clinical safety and toxicity of the treatment. INCLUSION CRITERIA: • Histological confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer stage I‐IV. • A: First line treatment with first line chemotherapy with a platinum‐based regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy. OR B: Patients receiving second line with a platinum‐based regimen with either progression or no response during second line chemotherapy, or relapse within 6 months after end of second line chemotherapy. • Maximum two prior lines of chemotherapy (both platinum‐based). • Age = 18 years. • Performance status 0‐2. • Measurable disease by CA125 GCIG criteria’s (evaluation of response according to CA 125 is used in this protocol). • KRAS wild type. • Adequate bone marrow fun