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

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Lilly

Status and phase

Completed
Phase 3

Conditions

Colorectal Cancer

Treatments

Drug: cetuximab
Drug: Irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00063141
CA225-006

Details and patient eligibility

About

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.

Enrollment

1,302 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,302 participants in 2 patient groups

Arm A
Experimental group
Treatment:
Drug: cetuximab
Drug: Irinotecan
Drug: Irinotecan
Arm B
Active Comparator group
Treatment:
Drug: Irinotecan
Drug: Irinotecan

Trial contacts and locations

188

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Data sourced from clinicaltrials.gov

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