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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00063141

Enrollment

1302

Registered

2003-06-25

Start date

2003-04-30

Completion date

2007-10-31

Last updated

2010-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DRUGcetuximab

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

DRUGIrinotecan

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia, Austria, Belgium, Czechia, Finland, France, Germany, Hong Kong, Italy, Netherlands, Norway, Portugal, Slovakia, Sweden, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026