A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer
- 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.
- 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-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
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial
pneumonitis or pulmonary fibrosis on baseline chest 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
- 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.