Study of IMC-11F8 in Participants With Colorectal Cancer

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antibodies, Monoclonal; Folic Acid; Leucovorin; Levoleucovorin; Necitumumab; Oxaliplatin

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