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Panitumumab-based Maintenance in Patients With RAS Wild-type, Metastatic Colorectal Cancer (Valentino)

ABSTRACT: Open label, randomized, multicenter, phase II study to compare the efficacy, in terms of non-inferiority of progression-free survival (PFS), of maintenance with panitumumab alone (arm B) as compared to panitumumab with 5-fluorouracil (5-FU) and leucovorin (LV) (arm A) following induction treatment with 5-fluorouracil + leucovorin+oxaliplatin (FOLFOX-4) and panitumumab in patients with RAS wild-type, metastatic colorectal cancer. The study involves an induction phase with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines. Before start of FOLFOX-4 plus panitumumab, at the time of enrollment, patients will be immediately randomized electronically 1:1 to one of the two maintenance arms. Induction treatment with FOLFOX-4 plus panitumumab will continue until progressive disease, unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of induction treatment, in presence of complete or partial response, or stable disease, non-progressing patients will be allocated to one of the two pre-assigned maintenance arms: A) 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal B) Panitumumab alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal Imaging studies (thorax and abdominal CT or MRI scan) will be performed at baseline (4 weeks prior enrollment) and every 8 weeks (4 cycles) during treatment.

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2192462 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention1: DRL_BZ (Bevacizumab): Part A: DRL_BZ, 5 mg/kg administered intravenously (i.v.) on day 1 as a 90 min infusion with the needed adjustments every two weeks in conjunction with mFOLFOX6. Patients will continue to be treated with their assigned treatment until documented progressive disease, death, unacceptable toxicity, withdrawal of consent or Investigator decision to discontinue in the best interest of patient or for 9 months, whichever occurs earlier. Part B: DRL_BZ; 15 mg/kg administered intravenously (i.v.) on day 1 every three weeks plus pemetrexed+carboplatin chemotherapy for 4 cycles. After 4 cycles, treatment will be continued with bevacizumab and pemetrexed only. Patients need to be premedicated with folic acid, vitamin B12 and dexamethasone as per institutional practice. Patients will be treated until documented progressive disease, death, unacceptable toxicity, patient withdrawal or Investigator decision to discontinue in the best interest of patient or up to 6 months Control Intervention1: AvastinÂ (Bevacizumab): AvastinÂ, 5 mg/kg administered intravenously (i.v.) on day 1 as a 90 min infusion with the needed adjustments every two weeks in conjunction with mFOLFOX6. Patients will continue to be treated with their assigned treatment until documented progressive disease, death, unacceptable toxicity, withdrawal of consent or Investigator decision to discontinue in the best interest of patient or for 9 months, whichever occurs earlier. Part B: AvastinÂ; 15 mg/kg administered intravenously (i.v.) on day 1 every three weeks plus pemetrexed+carboplatin chemotherapy for 4 cycles. After 4 cycles, treatment will be continued with bevacizumab and pemetrexed only. Patients need to be premedicated with folic acid, vitamin B12 and dexamethasone as per in Primary outcome(s): PART A: To compare the efficacy measured in terms of progression free survival at 9 months (PFS9) of two anti-VEGF antibodies administered in combination with chemotherapy for mCRC (stage IV) as first-line treatment for metastatic disease. PART B: To compare the efficacy measured in terms of progression free survival at 6 months (PFS6) of two anti-VEGF antibodies administered in combination with chemotherapy for recurrent or advanced non-squamous NSCLC not previously treated with chemotherapy.Timepoint: 9 months Study Design: Randomized, Parallel Group, Multiple Arm Trial Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

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Panitumumab-based Maintenance in Patients With RAS Wild-type, Metastatic Colorectal Cancer (Valentino)

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