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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Recruitment postcode(s) [2] 0 0
- Sydney
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- Wollongong
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- South Brisbane
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- Adelaide
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- Wien
Recruitment outside Australia
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Hampshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImClone LLC
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/show/NCT00063141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
E-mail: ClinicalTrials@ ImClone.com
Address 0 0
ImClone LLC
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
Other publications