Trial | NCT01358812  Report issue

Title

FOLFOXIRI Plus Panitumumab In Kras and Braf Wild-Type Metastatic Colorectal Cancer
Phase II Trial of FOLFOXIRI Plus Panitumumab as First-Line Treatment for Kras and Braf Wild-Type Metastatic Colorectal Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    37
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 Started
Mar 31
2010
Primary Completion
Oct 31
2011
Last Update
Mar 11
2015
Estimate

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.

FOLFOXIRI + Panitumumab Experimental

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.

Criteria 

Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma;
Availability of formalin-fixed paraffin embedded tumor block from primary or metastasis;
KRAS and BRAF wild-type status of primary colorectal cancer or related metastasis;
Unresectable and measurable metastatic disease according to RECIST criteria;
Male or female, aged >/= 18 years and </= 75 years;
ECOG PS < 2 if aged < 71 years;
ECOG PS = 0 if aged 71-75 years;
Life expectancy of more than 3 months;
Adequate haematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL;
Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases < 5 x ULN);
Serum creatinine ≤ 1.5 x ULN;
Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
At least 6 weeks from prior radiotherapy and 4 weeks from surgery;
Written informed consent to experimental treatment and pharmacogenomic analyses;
Magnesium ≥ lower limit of normal;
Calcium ≥ lower limit of normal.

Exclusion Criteria:

Prior palliative chemotherapy;
Prior treatment with EGFR inhibitors;
Symptomatic peripheral neuropathy ≥ 2 grade NCIC-CTG criteria;
Presence or history of CNS metastasis;
Active uncontrolled infections; active disseminated intravascular coagulation;
Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;
Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception;
Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment;
History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
No Results Posted