Know Cancer

forgot password

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

Phase 2
18 Years
75 Years
Open (Enrolling)
Metastatic Colo-rectal Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- Histologically confirmed colorectal adenocarcinoma;

- Availability of formalin-fixed paraffin embedded tumor block from primary or

- 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
- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Description:

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.

Outcome Time Frame:

Up to 3 years (objective response will be evaluated every 8 weeks)

Safety Issue:


Principal Investigator

Alfredo Falcone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Polo Oncologico Area Vasta Nord-Ovest


Italy: Italian Agency for Drugs (AIFA)

Study ID:




Start Date:

March 2010

Completion Date:

January 2013

Related Keywords:

  • Metastatic Colo-rectal Cancer
  • RAS Wild-Type
  • BRAF Wild-Type
  • Rectal Neoplasms
  • Colorectal Neoplasms