Study of IMC-11F8 in Participants With Colorectal Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Folinic acid (FA)

Drug: Oxaliplatin

Biological: IMC-11F8 (necitumumab)

Drug: 5-FU

Study type

Interventional

Funder types

Industry

Identifiers

NCT00835185

13926

2006-003147-23 (EudraCT Number)

CP11-0602 (Other Identifier)

I4X-IE-JFCD (Other Identifier)

Details and patient eligibility

About

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

Full description

The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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