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Study of IMC-11F8 in Patients With Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: February 2, 2009   Last Updated: May 5, 2009   History of Changes
Sponsored by: ImClone Systems
Information provided by: ImClone Systems
ClinicalTrials.gov Identifier: NCT00835185
  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
Other: mFOLFOX-6 regimen
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by ImClone Systems:

Primary Outcome Measures:
  • Anti-Tumor Activity of IMC-11F8 [ Time Frame: Every 4 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: Every 4 cycle ] [ Designated as safety issue: No ]
  • Safety Profile [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: Every 4 cycles ] [ Designated as safety issue: No ]
  • Pharmacokinetic Profile & Immunogenicity [ Time Frame: Cycles 1-6 and end of treatment ] [ Designated as safety issue: Yes ]
  • Association between response to treatment and the presence or absence of KRAS mutations in tumor tissue [ Time Frame: Every 4 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: August 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
All patients will receive intravenous infusions of IMC-11F8 followed by administration of the mFOLFOX-6 regimen.
Biological: IMC-11F8
Patients will receive IMC-11F8 800mg on Day 1 administered intravenously over 50 minutes. Followed by the mFOLFOX-6 regimen.
Other: mFOLFOX-6 regimen
Oxaliplatin 85mg/m2 intravenous infusion over 2 hours Day 1 Folinic Acid 400mg/m2 intravenous infusion over 2 hours Day 1 5-FU 400mg/m2 bolus injection immediately following folinic acid infusion 5-FU 2400mg/m2 intravenous infusion over 46 hours immediately following bolus injection (5-FU on Days 1 and 2

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
  • ECOG performance status ≤ 2 at study entry
  • Adequate hematologic function, as evidenced by an ANC ≥ 1.5 x 109/L, hemoglobin ≥ 10g/dL, and platelets ≥ 100 x 109/L
  • Adequate hepatic function as defined by a total bilirubin ≤ 1.5mg/dL, AST and ALT ≤ 2.5 x ULN, and alkaline phosphatase ≤ 2.5 x ULN
  • Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN, creatinine clearance ≥ 60mL/min, or serum albumin ≥ LLN
  • 10.Patient's relevant toxicities/effects of prior therapy must have recovered to a stable or chronic level
  • 11.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.
  • 12.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 > 10mg/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
Spain
Hospital Universitario Clinico De Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
ImClone Systems
Investigators
Study Director: Andres Cervantes, MD Hospital Universitario Clinico De Valencia
  More Information

No publications provided

Responsible Party: ImClone Systems ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers: CP11-0602
Study First Received: February 2, 2009
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00835185     History of Changes
Health Authority: Spain: Agencia Espanola Del Medicamento Y Productos Sanitarios;   Spain: Comite de Investigacion Clinica Del Hospital Vall d' Hebron

Keywords provided by ImClone Systems:
Antibodies, Monoclonal
Colorectal Neoplasms

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Antibodies, Monoclonal
Folic Acid
Antibodies
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009