Study of IMC-11F8 in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00835185
First received: February 2, 2009
Last updated: January 22, 2014
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Metastatic Colorectal Cancer
Biological: IMC-11F8 (Necitumumab)
Other: mFOLFOX-6 regimen
Drug: Folinic acid
Drug: 5-FU
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall response (OOR) [ Time Frame: Approximately 30 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Clearance (Cl) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Volume of Distribution (Vss) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Clearance (Cl) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Volume of Distribution (Vss) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Change from baseline in tumor size [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • KRAS mutation status [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
    Tumor tissue samples will be screened for the presence or absence of KRAS mutations


Enrollment: 44
Study Start Date: August 2007
Study Completion Date: October 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
Participants will receive IMC-11F8 (necitumumab) once every two weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
Biological: IMC-11F8 (Necitumumab)
IMC-11F8 800 mg intravenous infusion over 50 minutes on Day 1
Other Names:
  • Necitumumab
  • IMC-11F8
Other: mFOLFOX-6 regimen
Oxaliplatin 85 mg/m2 intravenous infusion over 2 hours Day 1
Drug: Folinic acid
5-FU 400 mg/m2 intravenous infusion bolus injection
Drug: 5-FU
2400 mg/m2 IV continuous infusion over 46 hours

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Eastern Cooperative Oncology Group (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 Upper Limit of Normal (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835185

Locations
Belgium
ImClone Investigational Site
Brussels, Belgium, 1000
ImClone Investigational Site
Haine Saint-Paul, Belgium, 7100
Spain
ImClone Investigational Site
Barcelona, Spain, 08035
ImClone Investigational Site
Madrid, Spain, 28040
ImClone Investigational Site
Valencia, Spain, 46010
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00835185     History of Changes
Other Study ID Numbers: 13926, 2006-003147-23, CP11-0602, I4X-IE-JFCD
Study First Received: February 2, 2009
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comite de Investigacion Clinica Del Hospital Vall d' Hebron

Keywords provided by Eli Lilly and Company:
Antibodies, Monoclonal
Colorectal Neoplasms

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Fluorouracil
Oxaliplatin
Leucovorin
Folic Acid
Levoleucovorin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 14, 2014