Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Panitumumab; FOLFIRI
Intervention description: Administered by intravenous infusion; FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m², leucovorin 400 mg/m², 5-fluorouracil bolus 400 mg/m², 5-fluorouracil infusion 2400 mg/m².
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective
      response rate and other measures of efficacy for patients treated with panitumumab in
      combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin
      (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of
             the colon and/or rectum.

          -  Measurable disease according to modified RECIST guidelines.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

          -  Paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour
             available for central lab analysis.

          -  Adequate haematologic, renal, hepatic and metabolic function.

        Exclusion Criteria:

          -  Central nervous system metastases.

          -  Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the
             exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months
             prior to initiating study treatment.

          -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g. cetuximab)
             or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).

          -  Prior radiotherapy within 14 days prior to screening, and for which all signs of early
             radiological toxicity have not abated.

          -  Significant cardiovascular disease including unstable angina or myocardial infarction
             within six months before initiating study treatment or a history of ventricular
             arrhythmia.

          -  History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial
             pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT scan.

          -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea
             (defined as > 4 loose stools per day).

          -  History of Gilbert's syndrome or dihydropyrimidine deficiency.

          -  Known positive test for human immunodeficiency virus infection, hepatitis C virus,
             chronic active hepatitis B infection.

          -  Any investigational agent within 30 days before initiation of study treatment.

          -  Must not have had a major surgical procedure within 28 days prior to initiation of
             study treatment.

          -  Subject who is pregnant or breast-feeding.

          -  Woman or man of childbearing potential not consenting to use adequate contraceptive
             precautions during the course of the study and for six months after the last study
             drug administration for women, and one month for men.

               -  Other protocol specified criteria and specific details may apply.