Study of IMC-11F8 in Participants With Colorectal Cancer

NCT ID: NCT00835185

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-10-31

Brief Summary

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

Detailed 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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMC-11F8 (necitumumab) /mFOLFOX-6 regimen

Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)

Group Type: EXPERIMENTAL

IMC-11F8 (necitumumab)

Intervention Type: BIOLOGICAL

IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1

Folinic acid (FA)

Intervention Type: DRUG

FA 400 mg/m² IV infusion bolus injection

5-FU

Intervention Type: DRUG

5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours

Interventions

IMC-11F8 (necitumumab)

IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1

Intervention Type: BIOLOGICAL

Oxaliplatin

Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1

Intervention Type: DRUG

Folinic acid (FA)

FA 400 mg/m² IV infusion bolus injection

Intervention Type: DRUG

5-FU

5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours

Intervention Type: DRUG

Other Intervention Names

Necitumumab; IMC-11F8; LY3012211; Portrazza®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Brussels, , Belgium

ImClone Investigational Site

Haine-Saint-Paul, , Belgium

ImClone Investigational Site

Barcelona, , Spain

ImClone Investigational Site

Madrid, , Spain

ImClone Investigational Site

Valencia, , Spain

Countries

Belgium; Spain

Other Identifiers

2006-003147-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CP11-0602

Identifier Type: OTHER

Identifier Source: secondary_id

I4X-IE-JFCD

Identifier Type: OTHER

Identifier Source: secondary_id

13926

Identifier Type: -

Identifier Source: org_study_id