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Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer

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Trial Information

Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer


Inclusion Criteria:



- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum

- Inoperable metastatic disease

- Immunohistochemical evidence of epidermal growth factor receptor expression in tumor
tissue

- Presence of at least 1 bi-dimensionally measurable index lesion

Exclusion Criteria:

- Previous irinotecan-based chemotherapy

- Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated
more than 6 months before the start of study treatment

- Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug
in the 30 days before the start of study treatment

- Brain metastasis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments

Outcome Description:

Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.

Outcome Time Frame:

Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Safety Issue:

No

Principal Investigator

Eric van Cutsem, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

EMR 62202-013

NCT ID:

NCT00154102

Start Date:

May 2004

Completion Date:

March 2011

Related Keywords:

  • Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
  • Metastatic colorectal cancer
  • EGFR
  • Irinotecan
  • cetuximab
  • first-line treatment
  • Colorectal Neoplasms

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