Clinical trial NCT00055419: A Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
Official title: A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: Stage IV colorectal cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2003-03-04
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Every 4 weeks untill disease progression
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: ImClone Investigational Site
state: California
city: Los Angeles
country: United States
facility: ImClone Investigational Site
state: California
city: Denver
country: United States
facility: ImClone Investigational Site
state: Colorado
city: Torrington
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Washington
country: United States
facility: ImClone Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: ImClone Investigational Site
state: Florida
city: Miami
country: United States
facility: ImClone Investigational Site
state: Florida
city: Orlando
country: United States
facility: ImClone Investigational Site
state: Florida
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Decatur
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Louisville
country: United States
facility: ImClone Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: ImClone Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: ImClone Investigational Site
state: Maryland
city: Ypsilanti
country: United States
facility: ImClone Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: ImClone Investigational Site
state: Minnesota
city: St Charles
country: United States
facility: ImClone Investigational Site
state: Missouri
city: Great Falls
country: United States
facility: ImClone Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: ImClone Investigational Site
state: Nevada
city: Voorhees
country: United States
facility: ImClone Investigational Site
state: New Jersey
city: East Setauket
country: United States
facility: ImClone Investigational Site
state: New York
city: Latham
country: United States
facility: ImClone Investigational Site
state: New York
city: New York City
country: United States
facility: ImClone Investigational Site
state: New York
city: Cleveland
country: United States
facility: ImClone Investigational Site
state: Ohio
city: Portland
country: United States
facility: ImClone Investigational Site
state: Oregon
city: Greenville
country: United States
facility: ImClone Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: ImClone Investigational Site
state: Texas
city: Norfolk
country: United States
facility: ImClone Investigational Site
state: Virginia
city: Green Bay
country: United States
facility: ImClone Investigational Site
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: E-mail: ClinicalTrials@ ImClone.com
role: STUDY_CHAIR
References: