A Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00055419
First received: February 28, 2003
Last updated: April 8, 2010
Last verified: April 2010
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: 400 mg/m2 Biological: Cetuximab
400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression
Other Name: Erbitux

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055419

  Hide Study Locations
Locations
United States, California
ImClone Investigational Site
Bakersfield, California, United States, 93309
ImClone Investigational Site
Los Angeles, California, United States, 90025
United States, Colorado
ImClone Investigational Site
Denver, Colorado, United States, 80218
United States, Connecticut
ImClone Investigational Site
Torrington, Connecticut, United States, 06790
United States, District of Columbia
ImClone Investigational Site
Washington, District of Columbia, United States, 20057
United States, Florida
ImClone Investigational Site
Jacksonville, Florida, United States, 32207
ImClone Investigational Site
Miami, Florida, United States, 33176
ImClone Investigational Site
Orlando, Florida, United States, 32804
United States, Georgia
ImClone Investigational Site
Atlanta, Georgia, United States, 30318
United States, Illinois
ImClone Investigational Site
Decatur, Illinois, United States, 62526
United States, Kentucky
ImClone Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
ImClone Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Maryland
ImClone Investigational Site
Baltimore, Maryland, United States, 21204
United States, Michigan
ImClone Investigational Site
Ypsilanti, Michigan, United States, 48198
United States, Minnesota
ImClone Investigational Site
Minneapolis, Minnesota, United States, 55416
United States, Missouri
ImClone Investigational Site
St Charles, Missouri, United States, 63301
United States, Montana
ImClone Investigational Site
Great Falls, Montana, United States, 59405
United States, Nevada
ImClone Investigational Site
Las Vegas, Nevada, United States, 89109
United States, New Jersey
ImClone Investigational Site
Voorhees, New Jersey, United States, 08043
United States, New York
ImClone Investigational Site
East Setauket, New York, United States, 11733
ImClone Investigational Site
Latham, New York, United States, 12110
ImClone Investigational Site
New York City, New York, United States, 10016
United States, Ohio
ImClone Investigational Site
Cleveland, Ohio, United States, 44134
United States, Oregon
ImClone Investigational Site
Portland, Oregon, United States, 97239
United States, South Carolina
ImClone Investigational Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
ImClone Investigational Site
Memphis, Tennessee, United States, 38104
United States, Texas
ImClone Investigational Site
Dallas, Texas, United States, 75230
United States, Virginia
ImClone Investigational Site
Norfolk, Virginia, United States, 23502
United States, Wisconsin
ImClone Investigational Site
Green Bay, Wisconsin, United States, 54307
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

No publications provided

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00055419     History of Changes
Other Study ID Numbers: CA225-041
Study First Received: February 28, 2003
Last Updated: April 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
Stage IV colorectal cancer

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

ClinicalTrials.gov processed this record on October 29, 2014