Colorectal CancerPhase 3NCT00061815
Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer
A Phase 3 study testing cetuximab, oxaliplatin and leucovorin in people with Colorectal Cancer, run by Eli Lilly and Company at 39 sites in United States.
Trial summary
The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cetuximab, oxaliplatin and leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 39 sitesUnited States
- Study dates
- Mar 2003to Nov 2005
- Phase
- Phase 3
- 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
- Documented colorectal cancer which is EGFR-positive and is metastatic.
- Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
Who cannot join
- A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Known metastases in the central nervous system.
- Symptomatic sensory or peripheral neuropathy.
- More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
- Prior oxaliplatin therapy.
- Prior cetuximab or other therapy which targets the EGF pathway.
- Prior chimerized or murine monoclonal antibody therapy.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
ImClone Investigational Site
Armonk, New York, 10504
ImClone Investigational Site
Atlanta, Georgia, 30309
ImClone Investigational Site
Baltimore, Maryland, 21225
ImClone Investigational Site
Baton Rouge, Louisiana, 70809
ImClone Investigational Site
Bismarck, North Dakota, 58501
ImClone Investigational Site
Boynton Beach, Florida, 33435
ImClone Investigational Site
Brooklyn, New York, 11235
ImClone Investigational Site
Charleston, South Carolina, 29406
ImClone Investigational Site
Clinton, Maryland, 20735
ImClone Investigational Site
East Setauket, New York, 11733
ImClone Investigational Site
Fountain Valley, California, 92708
ImClone Investigational Site
Gilroy, California, 95020
ImClone Investigational Site
Greenbrae, California, 94904
ImClone Investigational Site
Hackensack, New Jersey, 07601
ImClone Investigational Site
Hartford, Connecticut, 06105
ImClone Investigational Site
Jacksonville, Florida, 32207
ImClone Investigational Site
Kansas City, Missouri, 64131
ImClone Investigational Site
Knoxville, Tennessee, 37920
ImClone Investigational Site
Leesburg, Florida, 34748
ImClone Investigational Site
Little Rock, Arkansas, 72205
ImClone Investigational Site
Louisville, Kentucky, 40202
ImClone Investigational Site
Macon, Georgia, 31201
ImClone Investigational Site
Nashville, Tennessee, 37203
ImClone Investigational Site
Norwalk, Connecticut, 06856
ImClone Investigational Site
Ogden, Utah, 84403
ImClone Investigational Site
Orange, California, 92868
ImClone Investigational Site
Orlando, Florida, 32804
ImClone Investigational Site
Philadelphia, Pennsylvania, 19107
ImClone Investigational Site
Pomona, California, 91767
ImClone Investigational Site
Richmond, Virginia, 23230
ImClone Investigational Site
Rolla, Missouri, 65401
ImClone Investigational Site
Saint Joseph, Michigan, 49085
ImClone Investigational Site
San Diego, California, 92120
ImClone Investigational Site
Springdale, Arkansas, 72764
ImClone Investigational Site
Stamford, Connecticut, 06902
ImClone Investigational Site
Tampa, Florida, 33613
ImClone Investigational Site
Vista, California, 92083
ImClone Investigational Site
Waterbury, Connecticut, 06708
ImClone Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma
The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.
- Conditions
- Colorectal Cancer
- Being tested
- cetuximab, oxaliplatin, leucovorin, 5-fluorouracil
- 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 IV
oxaliplatinDrug
Also called Eloxatin®
85 mg/m2 IV
leucovorinDrug
Also called Wellcovorin®
200 mg/m2 IV
5-fluorouracilDrug
Also called 5-FU
400 mg/m2 IV
5-fluorouracilDrug
Also called 5-FU
600 mg/m2 IV
cetuximabBiological
Also called Erbitux™
250 mg/m2 IV
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab+FOLFOX4 | Experimental | * Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion
* Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion
* Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes Receives: Biological: cetuximab; Drug: oxaliplatin; Drug: leucovorin; Drug: 5-fluorouracil |
| FOLFOX4. | Active comparator | * Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion.
* Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion. Receives: Drug: oxaliplatin; Drug: leucovorin; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.
Measured: Every six weeks
Secondary outcomes (7)
Compare the response rates between the two treatment arms.
Measured: Every six weeks
Compare progression-free survival between the two treatment arms.
Measured: Every six weeks
Duration of response within each treatment arm.
Measured: Every six weeks
Time to response within each treatment arm.
Measured: Every six weeks
Compare the safety profiles between the two treatment arms.
Measured: Every six weeks
Compare the quality of life (QOL)between the two treatment arms.
Measured: Every six weeks
Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.
Measured: Every six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMar 2003
- Primary completionDec 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT00061815
- Sponsor's protocol ID
- CA225-014
- Status last verified
- Apr 2010
- First submitted
- 4 Jun 2003
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00061815
- Acronym / sponsor ID
- CA225-014
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 6 Jun 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 study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab+FOLFOX4 | Experimental | Biological: cetuximab, Drug: oxaliplatin, Drug: leucovorin, Drug: 5-fluorouracil* Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion * Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion * Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes |
| FOLFOX4. | Active comparator | Drug: oxaliplatin, Drug: leucovorin, Drug: 5-fluorouracil* Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion. * Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented colorectal cancer which is EGFR-positive and is metastatic.
- Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
Key exclusion criteria (8 listed)
- A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Known metastases in the central nervous system.
- Symptomatic sensory or peripheral neuropathy.
- More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
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: Erbitux™400 mg/m2 IV | Biological | Cetuximab+FOLFOX4 |
| oxaliplatinAlso: Eloxatin®85 mg/m2 IV | Drug | Cetuximab+FOLFOX4, FOLFOX4. |
| leucovorinAlso: Wellcovorin®200 mg/m2 IV | Drug | Cetuximab+FOLFOX4, FOLFOX4. |
| 5-fluorouracilAlso: 5-FU400 mg/m2 IV | Drug | Cetuximab+FOLFOX4, FOLFOX4. |
| 5-fluorouracilAlso: 5-FU600 mg/m2 IV | Drug | Cetuximab+FOLFOX4, FOLFOX4. |
| cetuximabAlso: Erbitux™250 mg/m2 IV | Biological | Cetuximab+FOLFOX4 |
Primary outcome
Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.
Time frame: Every six weeks
7 secondary outcomes
Compare the response rates between the two treatment arms.
Time frame: Every six weeks
Compare progression-free survival between the two treatment arms.
Time frame: Every six weeks
Duration of response within each treatment arm.
Time frame: Every six weeks
Time to response within each treatment arm.
Time frame: Every six weeks
Compare the safety profiles between the two treatment arms.
Time frame: Every six weeks
Compare the quality of life (QOL)between the two treatment arms.
Time frame: Every six weeks
Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.
Time frame: Every six weeks
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 12 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
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cetuximab, oxaliplatin and leucovorin in people with Colorectal Cancer, run by Eli Lilly and Company at 39 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 2 inclusion and 8 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 12 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 39 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone. (time frame: Every six weeks). 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 12 Apr 2010.