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A Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
This study has been completed.
First Received: February 28, 2003   Last Updated: August 18, 2009   History of Changes
Sponsor: ImClone LLC
Collaborator: Bristol-Myers Squibb
Information provided by: ImClone LLC
ClinicalTrials.gov Identifier: NCT00055419
  Purpose

The purpose of this clinical research study is to learn about the safety of cetuximab in patients with stage IV colorectal cancer, and who may benefit from cetuximab.


Condition Intervention Phase
Colorectal Neoplasms
Biological: Cetuximab
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • The objective of this study will be to monitor the safety of administering cetuximab,via an access program, to subjects with metastatic colorectal carcinoma who have exhausted all standard therapies or treatment options. [ Time Frame: Every 4 weeks untill disease progression ] [ Designated as safety issue: Yes ]

Enrollment: 744
Study Start Date: February 2003
Study Completion Date: August 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
400 mg/m2: Experimental Biological: Cetuximab
400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression

  Eligibility

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

Inclusion Criteria:

  • Subjects must have signed an approved informed consent prior to any study procedures.
  • Subjects with histologically or pathologically confirmed metastatic colorectal cancer, which is EGFR-positive by IHC (may be based on archival samples)
  • Subjects with ECOG performance status 0, 1 or 2.
  • Subjects who have failed, either due to lack of efficacy or due to intolerance, all available chemotherapy for the treatment of metastatic colorectal cancer.
  • Subjects who have failed to meet eligibility criteria for any other existing cetuximab trial.
  • Subjects must have received at least two chemotherapy regimens for metastatic disease OR adjuvant therapy plus one chemotherapy regimen for metastatic disease, provided the subject progressed within 6 months of completing their adjuvant therapy.
  • Prior chemotherapy must have included all of the follow drugs: irinotecan, oxaliplatin, and a fluoropyrimidine.
  • Subjects adequately recovered from any recent surgery, radiation therapy or chemotherapy.
  • Subjects accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating center.
  • Subjects greater or equal to 18 years of age.
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks afterwards.

Exclusion Criteria:

  • Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Sexually active, fertile men not using adequate birth control.
  • Subjects with dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Subjects with a serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy.
  • Subjects with a history of uncontrolled angina, arrhythmias, congestive heart failure, or myocardial infarction within the previous 6 months.
  • Subjects with any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. Subjects with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial.
  • Subjects with any history of severe hypersensitivity reactions and/or anaphylaxis resulting from the administration of protein based therapeutic agents.
  • Subjects with inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,250/mm3, a platelet count <75,000/mm3, and a hemoglobin level <8 g/dL.
  • Subjects with inadequate hepatic function, defined by a total bilirubin level ³3 times the upper limit of normal (ULN) and an aspartate transaminase (AST) and alanine transaminase (ALT) levels >5 x ULN.
  • Subjects with inadequate renal function defined by a serum creatinine level >2.5 x ULN.
  • Prior cetuximab therapy, prior randomization on a study which includes cetuximab therapy in a treatment arm, or any other prior therapy that targets the EGFR pathway.
  • A history of prior therapy with a chimerized or murine monoclonal antibody.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
  • A history of cetuximab or therapy that targeted the EGFR receptor.
  • A history of prior anti-cancer murine monoclonal antibody therapy.
  • Additional concurrent chemotherapy or other investigational anticancer agents may not be administered to subjects on this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055419

  Hide Study Locations
Locations
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Cancer Institute Medical Group
Los Angeles, California, United States
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States
United States, Connecticut
Northwestern Connecticut Oncology/Hemaology Associates
Torrington, Connecticut, United States
United States, District of Columbia
Georgetown Univerisity Medical Center
Washington, District of Columbia, United States
United States, Florida
Oncology Hematology Group of South Florida
Miami, Florida, United States
Hematology and Oncology Consultants
Orlando, Florida, United States
Florida Oncology Asociates
Jacksonville, Florida, United States
United States, Georgia
Peachtree Hematology and Oncology
Atlanta, Georgia, United States
United States, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States
United States, Kentucky
Kentuckianna Cancer Institute
Louisville, Kentucky, United States
United States, Louisiana
Ochsner Cancer Center
New Orleans, Louisiana, United States
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States
United States, Michigan
McCauley Cancer Center
Ypsilanti, Michigan, United States
United States, Minnesota
Park Nicollet Cancer Center
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Missouri Cancer Care
St Charles, Missouri, United States
United States, Montana
Benefits Healthcare Hospital
Great Falls, Montana, United States
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Cooper Health System Cancer Center
Voorhees, New Jersey, United States
United States, New York
NYOH
Latham, New York, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
New York University Medical Center
New York City, New York, United States
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States
United States, Oregon
Oregon Hematology Oncology Associates, P.C.
Portland, Oregon, United States
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
United States, Tennessee
Memphis Cancer Center
Memphis, Tennessee, United States
United States, Texas
Center for Oncology Research and Treatment
Dallas, Texas, United States
United States, Virginia
Virginia Oncology Associates-Mid-Atlantic Consultants in Hem/Onc
Norfolk, Virginia, United States
United States, Wisconsin
Green Bay Oncology
Green Bay, Wisconsin, United States
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: ImClone LLC ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers: CA225-041
Study First Received: February 28, 2003
Last Updated: August 18, 2009
ClinicalTrials.gov Identifier: NCT00055419     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
Stage IV colorectal cancer

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Cetuximab
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009