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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00063141




Registration number
NCT00063141
Ethics application status
Date submitted
20/06/2003
Date registered
25/06/2003
Date last updated
12/04/2010

Titles & IDs
Public title
Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
Scientific 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
Secondary ID [1] 0 0
CA225-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cetuximab
Treatment: Drugs - Irinotecan
Treatment: Drugs - Irinotecan

Experimental: Arm A -

Active comparator: Arm B -


Treatment: Drugs: cetuximab
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision

Treatment: Drugs: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision

Treatment: Drugs: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Every 3 months after subject off-treatment
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Q6 Weeks
Secondary outcome [2] 0 0
Response
Timepoint [2] 0 0
Q6 Weeks
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Q6 Weeks
Secondary outcome [4] 0 0
Time to Response
Timepoint [4] 0 0
Q6 Weeks
Secondary outcome [5] 0 0
Disease Control Rate
Timepoint [5] 0 0
Q6 Weeks
Secondary outcome [6] 0 0
Safety
Timepoint [6] 0 0
Q3 Weeks
Secondary outcome [7] 0 0
Quality of Life
Timepoint [7] 0 0
Q6 Weeks
Secondary outcome [8] 0 0
Health Economics
Timepoint [8] 0 0
Q3 Weeks

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
1302
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA
Recruitment hospital [1] 0 0
ImClone Investigational Site - Perth
Recruitment hospital [2] 0 0
ImClone Investigational Site - Sydney
Recruitment hospital [3] 0 0
ImClone Investigational Site - Wollongong
Recruitment hospital [4] 0 0
ImClone Investigational Site - South Brisbane
Recruitment hospital [5] 0 0
ImClone Investigational Site - Adelaide
Recruitment hospital [6] 0 0
ImClone Investigational Site - Wien
Recruitment postcode(s) [1] 0 0
- Perth
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- Sydney
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- Wollongong
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- South Brisbane
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Wien
Recruitment outside Australia
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Central
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Dorset
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Greater London
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Hampshire
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
Trial website
https://clinicaltrials.gov/study/NCT00063141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
E-mail: ClinicalTrials@ ImClone.com
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00063141