FOLFOXIRI Plus Panitumumab In Kras and Braf Wild-Type Metastatic Colorectal Cancer (TRIP)
The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in a phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other RAS rare mutations have been suggested as additional potential biomarkers for anti-EGFR agents in metastatic colo-rectal cancer. The present study aims to demonstrate the feasibility and the activity of the first-line combination of the GONO-FOLFOXIRI regimen and Panitumumab in molecularly selected metastatic colo-rectal cancer patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of FOLFOXIRI Plus Panitumumab as First-Line Treatment for Kras and Braf Wild-Type Metastatic Colorectal Cancer|
- Response Rate [ Time Frame: Up to 3 years (objective response will be evaluated every 8 weeks) ] [ Designated as safety issue: No ]Response rate is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria vers. 1.1.
- Progression Free Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Progression free survival is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment.
- Overall Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Overall survival is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point.
- Safety Profile [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Safety Profile is based on the collection of all the adverse events occurring during the study graded by NCI-CTC criteria.
- Secondary Radical Surgery on Metastases [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Secondary Radical Surgery on Metastases is defined as microscopically margin-free complete surgical removal of all residual disease performed during treatment or after its completion allowed by tumoral shrinkage and or desappearance of one or more lesions.
- Analyses of Potential Predictive Factors [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Exploratory analyses of potential predictive factors and surrogate markers of treatment activity or efficacy.
|Study Start Date:||March 2010|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: FOLFOXIRI + Panitumumab
PANITUMUMAB 6 mg/Kg i.v. over 1 hour followed by IRINOTECAN 150 mg/sqm i.v. over 1 hour followed by OXALIPLATIN 85 mg/sqm i.v. over 2 hours concomitantly with L-LV 200 mg/sqm over 2 hours followed by 5-FLUOROURACIL 2400 mg/sqm c.i. over 48 hours starting on day 1 repeated every 2 weeks.
Drug: FOLFOXIRI + Panitumumab
PANITUMUMAB 6 mg/Kg i.v. over 1 hour followed by IRINOTECAN 150 mg/sqm i.v. over 1 hour followed by OXALIPLATIN 85 mg/sqm i.v. over 2 hours concomitantly with L-LV 200 mg/sqm over 2 hours followed by 5-FLUOROURACIL* 2400 mg/sqm c.i. over 48 hours starting on day 1 repeated every 2 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358812
|P.O. Zona Aretina - Ospedale S. Donato Di Arezzo|
|Istituto Nazionale Per La Ricerca Sul Cancro|
|Genova, Italy, 16132|
|IRCCS Ospedale San Raffaele|
|Milano, Italy, 20132|
|Asl Olbia - Uo Oncologia Ospedale San Giovanni Di Dio|
|Olbia, Italy, 07026|
|Istituto Oncologico Veneto (IOV)|
|Padova, Italy, 35100|
|Polo Oncologico Area Vasta Nord-Ovest|
|Pisa, Italy, 56126|
|Universita' Campus Bio-Medico Di Roma|
|Roma, Italy, 00128|
|Asl Di Sassari - Ospedale S.S. Annunziata -U.O. Oncologia Medica|
|Sassari, Italy, 07100|
|Ausl 7 Di Siena|
|Siena, Italy, 53100|
|A.O. Universitaria S.Maria Della Misericordia Di Udine|
|Udine, Italy, 33100|
|Principal Investigator:||Alfredo Falcone, MD||Polo Oncologico Area Vasta Nord-Ovest|