Study of IMC-11F8 in Participants With Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: IMC-11F8 (necitumumab); Oxaliplatin; Folinic acid (FA); 5-FU
Intervention description: IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1; Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1; FA 400 mg/m² IV infusion bolus injection; 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours
Intervention MeSH terms: Leucovorin; Folic Acid; Oxaliplatin; Necitumumab; Levoleucovorin; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies, Monoclonal; Colorectal Neoplasms

Summary:

      The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is
      effective in treating colorectal cancer (CRC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC

          -  Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum

          -  At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or
             magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated
             area

          -  Age ≥18 years

          -  Life expectancy of ≥6 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at study entry

          -  Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5
             x 10^9 liter (L), hemoglobin ≥10 grams per deciliter (g/dL), and platelets ≥100 x
             10^9/L

          -  Adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per
             deciliter (mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
             ≤2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and
             alkaline phosphatase (AP) ≤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 milliliters per minute (mL/min), or serum albumin ≥lower limit of
             normal (LLN)

          -  Participant's relevant toxicities/effects of prior therapy [surgery/radiation therapy
             (RT)] must have recovered to a stable or chronic level

          -  Participant agrees to use adequate contraception during the study period and for 4
             weeks after the last dose of study treatment. Participants must notify the principal
             investigator if they themselves or their partner becomes pregnant.

          -  Participant 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 EGFR

          -  Has serious concomitant medical conditions including active uncontrolled infection or
             cardiac disease, which in the opinion of the investigator, could compromise the
             participant or study.

          -  On chronic non-topical corticosteroid treatment for >6 months at doses >10 milligrams
             per day (mg/day) of prednisolone or equivalent before study entry, which in the
             opinion of the investigator could compromise the participant 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