Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer
Inclusion Criteria:
- Histologically-confirmed, EGFR-detectable or EGFR-undetectable colorectal cancer
- Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum
- At least one unidimensional-measurable target lesion by CT scan or MRI; target
lesion(s) must not lie within an irradiated area
- Age ≥ 18 years
- Life expectancy of ≥ 6 months
- ECOG performance status ≤ 2 at study entry
- Adequate hematologic function, as evidenced by an ANC ≥ 1.5 x 10^9 L, hemoglobin ≥ 10
g/dL, and platelets ≥ 100 x 10^9/L
- Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, AST and ALT ≤
2.5 x ULN, and alkaline phosphatase ≤ 2.5 x ULN (or 5.0 x ULN in the case of liver
metastases)
- Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN, creatinine
clearance ≥ 60 mL/min, or serum albumin ≥ LLN
- Patient's relevant toxicities/effects of prior therapy (surgery/RT) must have
recovered to a stable or chronic level
- Patient agrees to use adequate contraception during the study period and for 4 weeks
after the last dose of study treatment. Patients must notify the principal
investigator if they themselves or their partner becomes pregnant.
- Patient has provided signed informed consent
Exclusion Criteria:
- Has received prior systemic chemotherapy for locally-advanced unresectable or
metastatic CRC.
- Has received prior radiotherapy to > 25% of bone marrow
- Has documented and/or symptomatic brain metastases
- Has participated in clinical studies of non-approved experimental agents or
procedures within 12 weeks of study entry
- Has received previous therapy with monoclonal antibodies
- Has received previous therapy with any agent that targets the epidermal growth factor
receptor
- Has serious concomitant medical conditions including active uncontrolled infection or
cardiac disease, which in the opinion of the investigator, could compromise the
patient or study.
- On chronic non-topical corticosteroid treatment for > 6 months at doses > 10 mg/day
of prednisolone or equivalent before study entry, which in the opinion of the
investigator could compromise the patient or the study
- Has a known dihydropyrimidine dehydrogenase deficiency
- Has a known allergy to any of the treatment components
- Has an acute or subacute intestinal occlusion
- Has peripheral neuropathy ≥ grade 2
- Has a history of other malignancies, with the exception of curatively treated
non-melanoma skin cancer or carcinoma in situ of the cervix
- If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin
test) or breast-feeding
- Has received a prior autologous or allogeneic organ or tissue transplantation
- Has interstitial pneumonia or interstitial fibrosis of the lung
- Has pleural effusion or ascites that causes ≥ grade 2 dyspnea
- Has psychological, familial, sociological, or geographical conditions which do not
permit adequate study follow-up, compliance with the protocol, or signature of
Informed Consent