Colorectal CancerPhase 3NCT00063141

Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer

A Phase 3 study testing cetuximab and Irinotecan in people with Colorectal Cancer, run by Eli Lilly and Company at 188 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a… 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 and Irinotecan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,302 participants
Where: 188 sitesin 17 countries
Study dates: Apr 2003to Oct 2007
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

Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.
Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or uracil/tegafur [UFT]), for the 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
Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
Known or documented brain metastases

Trial locations and contacts

188 sites in 17 countries.

Country

City, postcode or hospital

188 sites in 17 countries

United States116 sites

ImClone Investigational Site
Albany, New York, 12208
ImClone Investigational Site
Ann Arbor, Michigan, 48106
ImClone Investigational Site
Arlington, Virginia, 22205
ImClone Investigational Site
Atlanta, Georgia, 30309
ImClone Investigational Site
Atlanta, Georgia, 30322
ImClone Investigational Site
Aurora, Colorado, 80012
ImClone Investigational Site
Austin, Texas, 78759
ImClone Investigational Site
Bakersfield, California, 93309
ImClone Investigational Site
Baltimore, Maryland, 21204
ImClone Investigational Site
Baton Rouge, Louisiana, 70808
ImClone Investigational Site
Berkeley, California, 94704
ImClone Investigational Site
Beverly Hills, California, 90211
ImClone Investigational Site
Bismarck, North Dakota, 58501
ImClone Investigational Site
Boston, Massachusetts, 02135
ImClone Investigational Site
Cincinnati, Ohio, 45267
ImClone Investigational Site
Cleveland, Ohio, 44106
ImClone Investigational Site
Columbus, Georgia, 31902-0951
ImClone Investigational Site
Columbus, Ohio, 43235
ImClone Investigational Site
Corona, California, 92708
ImClone Investigational Site
Dallas, Texas, 75230
ImClone Investigational Site
Danville, Virginia, 24541
ImClone Investigational Site
Dayton, Ohio, 45459
ImClone Investigational Site
Denver, Colorado, 80218
ImClone Investigational Site
Detroit, Michigan, 48201
ImClone Investigational Site
Durham, North Carolina, 27710
ImClone Investigational Site
East Setauket, New York, 11733
ImClone Investigational Site
Fort Myers, Florida, 33901
ImClone Investigational Site
Fort Myers, Florida, 33990
ImClone Investigational Site
Frederick, Maryland, 21701
ImClone Investigational Site
Gilroy, California, 95020
ImClone Investigational Site
Green Bay, Wisconsin, 54301
ImClone Investigational Site
Greenbrae, California, 95904
ImClone Investigational Site
Greenville, North Carolina, 27834
ImClone Investigational Site
Greenville, South Carolina, 29615
ImClone Investigational Site
Hershey, Pennsylvania, 17033
ImClone Investigational Site
High Point, North Carolina, 27262
ImClone Investigational Site
Honolulu, Hawaii, 96813
ImClone Investigational Site
Houston, Texas, 77030
ImClone Investigational Site
Inverness, Florida, 34452
ImClone Investigational Site
Jackson, Mississippi, 39202
ImClone Investigational Site
Jacksonville, Florida, 32207
ImClone Investigational Site
Jacksonville, Florida, 32209
ImClone Investigational Site
Jacksonville, Florida, 32224
ImClone Investigational Site
Kansas City, Kansas, 66160
ImClone Investigational Site
Kansas City, Missouri, 64111
ImClone Investigational Site
Knoxville, Tennessee, 37916
ImClone Investigational Site
Lafayette, Louisiana, 70506
ImClone Investigational Site
Lakeland, Florida, 33805
ImClone Investigational Site
Latham, New York, 12110
ImClone Investigational Site
Lexington, Kentucky, 40536-0098
ImClone Investigational Site
Long Beach, California, 90813
ImClone Investigational Site
Los Angeles, California, 90033
ImClone Investigational Site
Los Angeles, California, 90057
ImClone Investigational Site
Louisville, Kentucky, 40202
ImClone Investigational Site
Macon, Georgia, 31201
ImClone Investigational Site
Madison, Wisconsin, 53792
ImClone Investigational Site
Memphis, Tennessee, 38120
ImClone Investigational Site
Metairie, Louisiana, 70006
ImClone Investigational Site
Miami, Florida, 33136
ImClone Investigational Site
Milwaukee, Wisconsin, 53226
ImClone Investigational Site
Mineola, New York, 11501
ImClone Investigational Site
Minneapolis, Minnesota, 55407-3799
ImClone Investigational Site
Montebello, California, 90640
ImClone Investigational Site
Naperville, Illinois, 60540
ImClone Investigational Site
Nashville, Tennessee, 37203
ImClone Investigational Site
New Haven, Connecticut, 06520
ImClone Investigational Site
New London, Connecticut, 06320
ImClone Investigational Site
New Port Richey, Florida, 34652
ImClone Investigational Site
New York, New York, 10016
ImClone Investigational Site
Newark, Ohio, 43055
ImClone Investigational Site
Newport News, Virginia, 23606
ImClone Investigational Site
Norwich, Connecticut, 06360
ImClone Investigational Site
Ogden, Utah, 84403
ImClone Investigational Site
Oklahoma City, Oklahoma, 73118
ImClone Investigational Site
Orange, California, 92868
ImClone Investigational Site
Orlando, Florida, 32806
ImClone Investigational Site
Overland Park, Kansas, 66214
ImClone Investigational Site
Palm Springs, California, 92262
ImClone Investigational Site
Philadelphia, Pennsylvania, 19106
ImClone Investigational Site
Philadelphia, Pennsylvania, 19107
ImClone Investigational Site
Philadelphia, Pennsylvania, 19141-3098
ImClone Investigational Site
Pine Bluff, Arkansas, 71603
ImClone Investigational Site
Pittsburgh, Pennsylvania, 15232
ImClone Investigational Site
Plano, Texas, 75075
ImClone Investigational Site
Port Saint Lucie, Florida, 34952
ImClone Investigational Site
Raleigh, North Carolina, 27609
ImClone Investigational Site
Rancho Mirage, California, 92270
ImClone Investigational Site
Rexford, New York, 12148
ImClone Investigational Site
Richmond, Kentucky, 40475
ImClone Investigational Site
Richmond, Virginia, 23230
ImClone Investigational Site
Robbinsdale, Minnesota, 55422
ImClone Investigational Site
Rolla, Missouri, 65401
ImClone Investigational Site
Saint Louis Park, Minnesota, 55426
ImClone Investigational Site
San Diego, California, 92120
ImClone Investigational Site
Savannah, Georgia, 31405
ImClone Investigational Site
Seattle, Washington, 98104
ImClone Investigational Site
Shreveport, Louisiana, 71103
ImClone Investigational Site
South Bend, Indiana, 46601
ImClone Investigational Site
Southfield, Michigan, 48075
ImClone Investigational Site
Spokane, Washington, 99204
ImClone Investigational Site
Spokane, Washington, 99218
ImClone Investigational Site
St Louis, Missouri, 63110
ImClone Investigational Site
Stamford, Connecticut, 06902
ImClone Investigational Site
Stockton, California, 95204
ImClone Investigational Site
Stony Brook, New York, 11794
ImClone Investigational Site
Temple, Texas, 76508
ImClone Investigational Site
The Bronx, New York, 10466
ImClone Investigational Site
Trenton, New Jersey, 08690
ImClone Investigational Site
Tucker, Georgia, 30342
ImClone Investigational Site
Tucson, Arizona, 85712
ImClone Investigational Site
Valhalla, New York, 10595
ImClone Investigational Site
Vallejo, California, 94589
ImClone Investigational Site
Voorhees Township, New Jersey, 08084
ImClone Investigational Site
Walla Walla, Washington, 99362
ImClone Investigational Site
Winston-Salem, North Carolina, 27103
ImClone Investigational Site
Winston-Salem, North Carolina, 27157

Other trials in United States

Germany18 sites

ImClone Investigational Site
Aschaffenburg
ImClone Investigational Site
Augsburg
ImClone Investigational Site
Dessau
ImClone Investigational Site
Dortmund
ImClone Investigational Site
Essen
ImClone Investigational Site
Hamburg
ImClone Investigational Site
Hanburg
ImClone Investigational Site
Kaiserslautern
ImClone Investigational Site
Kassel
ImClone Investigational Site
Magdeburg
ImClone Investigational Site
Mainz
ImClone Investigational Site
Mannheim
ImClone Investigational Site
Muchnhen
ImClone Investigational Site
München
ImClone Investigational Site
Regensburg
ImClone Investigational Site
Saarbrücken
ImClone Investigational Site
Stralsund
ImClone Investigational Site
Stuttgart

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Italy14 sites

ImClone Investigational Site
Ancona
ImClone Investigational Site
Bergamo
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Candiolo
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Florence
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Genova
ImClone Investigational Site
Livomo
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Milan
ImClone Investigational Site
Modena
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Naples
ImClone Investigational Site
Perugia
ImClone Investigational Site
Reggio Emilia
ImClone Investigational Site
Roma
ImClone Investigational Site
Rome
ImClone Investigational Site
Rozzano, Milano

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United Kingdom8 sites

ImClone Investigational Site
Bournemouth, Hampshire
ImClone Investigational Site
Foresterhill, Aberdeenshire
ImClone Investigational Site
Glasgow, Central
ImClone Investigational Site
Guildford, Surrey
ImClone Investigational Site
Hull, Avon
ImClone Investigational Site
London, Greater London
ImClone Investigational Site
Poole, Dorset
ImClone Investigational Site
Sutton, Surrey

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Australia7 sites

ImClone Investigational Site
Adelaide, South Australia
ImClone Investigational Site
Perth, Australian Capital Territory
ImClone Investigational Site
South Brisbane, Queensland
ImClone Investigational Site
Sydney, Australian Capital Territory
ImClone Investigational Site
Sydney, New South Wales
ImClone Investigational Site
Wien
ImClone Investigational Site
Wollongong, New South Wales

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Austria4 sites

ImClone Investigational Site
Graz
ImClone Investigational Site
Salzburg
ImClone Investigational Site
Vienna
ImClone Investigational Site
Wein

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France4 sites

ImClone Investigational Site
Avignon
ImClone Investigational Site
Marseille
ImClone Investigational Site
Nice
ImClone Investigational Site
Saint-Herblain

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Czechia3 sites

ImClone Investigational Site
Brno
ImClone Investigational Site
Olomouc
ImClone Investigational Site
Prague

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Switzerland3 sites

ImClone Investigational Site
Bern
ImClone Investigational Site
Liestal
ImClone Investigational Site
Zurich

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Netherlands2 sites

ImClone Investigational Site
Apeldoorn
ImClone Investigational Site
Dordrecht

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Norway2 sites

ImClone Investigational Site
Montebello, Oslo
ImClone Investigational Site
Oslo

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Sweden2 sites

ImClone Investigational Site
Lund
ImClone Investigational Site
Stockholm

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Belgium1 site

ImClone Investigational Site
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Finland1 site

ImClone Investigational Site
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Hong Kong1 site

ImClone Investigational Site
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Portugal1 site

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Slovakia1 site

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About this study

Official title: Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma

Conditions: Colorectal Cancer
Being tested: cetuximab, Irinotecan
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cetuximabDrug
Also called Erbitux
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
IrinotecanDrug
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
IrinotecanDrug
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision

Study groups in NCT00063141
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: cetuximab; Drug: Irinotecan
Arm B	Active comparator	Not described Receives: Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Measured: Every 3 months after subject off-treatment

Secondary outcomes (8)

Progression Free Survival
Measured: Q6 Weeks
Response
Measured: Q6 Weeks
Duration of Response
Measured: Q6 Weeks
Time to Response
Measured: Q6 Weeks
Disease Control Rate
Measured: Q6 Weeks
Safety
Measured: Q3 Weeks
Quality of Life
Measured: Q6 Weeks
Health Economics
Measured: Q3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2003Oct 2007

First posted25 Jun 2003 (estimated)
Study startApr 2003
Primary completionJun 2006
Study completionOct 2007

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: 1,302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00063141
Sponsor's protocol ID: CA225-006
Status last verified: Apr 2010
First submitted: 20 Jun 2003
Last updated: 12 Apr 2010
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
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Natural History Study of Early Life Exposures in Agriculture (ELEA)
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All Colorectal Cancer trials

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: Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
ClinicalTrials.gov ID: NCT00063141
Acronym / sponsor ID: CA225-006
Conditions: Colorectal Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,302 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Apr 2003
Primary completion: Jun 2006 (actual)
Study completion: Oct 2007 (actual)
First posted: 25 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: cetuximab, Drug: Irinotecan
Arm B	Active comparator	Drug: Irinotecan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.
Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or uracil/tegafur [UFT]), for the first-line treatment of metastatic disease.

Key exclusion criteria (3 listed)

A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy
Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
Known or documented brain metastases

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: ErbituxVial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision	Drug	Arm A
IrinotecanVial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision	Drug	Arm A
IrinotecanVial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision	Drug	Arm B

Primary outcome

Overall Survival
Time frame: Every 3 months after subject off-treatment

8 secondary outcomes

Progression Free Survival
Time frame: Q6 Weeks
Response
Time frame: Q6 Weeks
Duration of Response
Time frame: Q6 Weeks
Time to Response
Time frame: Q6 Weeks
Disease Control Rate
Time frame: Q6 Weeks
Safety
Time frame: Q3 Weeks
Quality of Life
Time frame: Q6 Weeks
Health Economics
Time frame: Q3 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.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

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

188 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cetuximab and Irinotecan in people with Colorectal Cancer, run by Eli Lilly and Company at 188 sites in 17 countries.

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 3 inclusion and 3 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 188 sites in United States, Germany, Italy, United Kingdom, Australia and 12 more countries. 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?

Overall Survival (time frame: Every 3 months after subject off-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00063141.

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.