Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer

A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer

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).

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.