Colorectal NeoplasmsPhase 2NCT00055419
A Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
A Phase 2 study testing Cetuximab in people with Colorectal Neoplasms, run by Eli Lilly and Company at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 29 sitesUnited States
- Study dates
- Feb 2003to Aug 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
ImClone Investigational Site
Atlanta, Georgia, 30318
ImClone Investigational Site
Bakersfield, California, 93309
ImClone Investigational Site
Baltimore, Maryland, 21204
ImClone Investigational Site
Cleveland, Ohio, 44134
ImClone Investigational Site
Dallas, Texas, 75230
ImClone Investigational Site
Decatur, Illinois, 62526
ImClone Investigational Site
Denver, Colorado, 80218
ImClone Investigational Site
East Setauket, New York, 11733
ImClone Investigational Site
Great Falls, Montana, 59405
ImClone Investigational Site
Green Bay, Wisconsin, 54307
ImClone Investigational Site
Greenville, South Carolina, 29605
ImClone Investigational Site
Jacksonville, Florida, 32207
ImClone Investigational Site
Las Vegas, Nevada, 89109
ImClone Investigational Site
Latham, New York, 12110
ImClone Investigational Site
Los Angeles, California, 90025
ImClone Investigational Site
Louisville, Kentucky, 40202
ImClone Investigational Site
Memphis, Tennessee, 38104
ImClone Investigational Site
Miami, Florida, 33176
ImClone Investigational Site
Minneapolis, Minnesota, 55416
ImClone Investigational Site
New Orleans, Louisiana, 70121
ImClone Investigational Site
New York, New York, 10016
ImClone Investigational Site
Norfolk, Virginia, 23502
ImClone Investigational Site
Orlando, Florida, 32804
ImClone Investigational Site
Portland, Oregon, 97239
ImClone Investigational Site
Saint Charles, Missouri, 63301
ImClone Investigational Site
Torrington, Connecticut, 06790
ImClone Investigational Site
Voorhees Township, New Jersey, 08043
ImClone Investigational Site
Washington D.C., District of Columbia, 20057
ImClone Investigational Site
Ypsilanti, Michigan, 48198
About this study
Official title: A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Cetuximab
- Keywords
- Stage IV colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabBiological
Also called Erbitux
400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression
| Study group | Role | What they receive |
|---|---|---|
| 400 mg/m2 | Experimental | Not described Receives: Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 4 weeks untill disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2003 (estimated)
- Study startFeb 2003
- Primary completionJul 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- E-mail: ClinicalTrials@ ImClone.com, Study chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055419
- Sponsor's protocol ID
- CA225-041
- Status last verified
- Apr 2010
- First submitted
- 28 Feb 2003
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00055419
- Acronym / sponsor ID
- CA225-041
- Conditions
- Colorectal Neoplasms
- Keywords
- Stage IV colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 4 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 400 mg/m2 | Experimental | Biological: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: Erbitux400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression | Biological | 400 mg/m2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E-mail: ClinicalTrials@ ImClone.com study chair
Eli Lilly and Company
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab in people with Colorectal Neoplasms, run by Eli Lilly and Company at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Every 4 weeks untill disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2010.