A Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
1 other identifier
interventional
744
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2003
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 28, 2003
CompletedFirst Posted
Study publicly available on registry
March 4, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedApril 9, 2010
April 1, 2010
1.4 years
February 28, 2003
April 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Every 4 weeks untill disease progression
Study Arms (1)
400 mg/m2
EXPERIMENTALInterventions
400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Bristol-Myers Squibbcollaborator
Study Sites (29)
ImClone Investigational Site
Bakersfield, California, 93309, United States
ImClone Investigational Site
Los Angeles, California, 90025, United States
ImClone Investigational Site
Denver, Colorado, 80218, United States
ImClone Investigational Site
Torrington, Connecticut, 06790, United States
ImClone Investigational Site
Washington D.C., District of Columbia, 20057, United States
ImClone Investigational Site
Jacksonville, Florida, 32207, United States
ImClone Investigational Site
Miami, Florida, 33176, United States
ImClone Investigational Site
Orlando, Florida, 32804, United States
ImClone Investigational Site
Atlanta, Georgia, 30318, United States
ImClone Investigational Site
Decatur, Illinois, 62526, United States
ImClone Investigational Site
Louisville, Kentucky, 40202, United States
ImClone Investigational Site
New Orleans, Louisiana, 70121, United States
ImClone Investigational Site
Baltimore, Maryland, 21204, United States
ImClone Investigational Site
Ypsilanti, Michigan, 48198, United States
ImClone Investigational Site
Minneapolis, Minnesota, 55416, United States
ImClone Investigational Site
Saint Charles, Missouri, 63301, United States
ImClone Investigational Site
Great Falls, Montana, 59405, United States
ImClone Investigational Site
Las Vegas, Nevada, 89109, United States
ImClone Investigational Site
Voorhees Township, New Jersey, 08043, United States
ImClone Investigational Site
East Setauket, New York, 11733, United States
ImClone Investigational Site
Latham, New York, 12110, United States
ImClone Investigational Site
New York, New York, 10016, United States
ImClone Investigational Site
Cleveland, Ohio, 44134, United States
ImClone Investigational Site
Portland, Oregon, 97239, United States
ImClone Investigational Site
Greenville, South Carolina, 29605, United States
ImClone Investigational Site
Memphis, Tennessee, 38104, United States
ImClone Investigational Site
Dallas, Texas, 75230, United States
ImClone Investigational Site
Norfolk, Virginia, 23502, United States
ImClone Investigational Site
Green Bay, Wisconsin, 54307, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
E-mail: ClinicalTrials@ ImClone.com
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 28, 2003
First Posted
March 4, 2003
Study Start
February 1, 2003
Primary Completion
July 1, 2004
Study Completion
August 1, 2004
Last Updated
April 9, 2010
Record last verified: 2010-04