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Phase 3
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Inclusion Criteria:

- Adult patients >/= 18 years of age

- Histologically confirmed adenocarcinoma of the colon or rectum

- Stage IV metastatic disease with at least one measurable metastatic lesion according
to RECIST criteria

- Tumour tissue sample available for assessment of K-RAS and BRAF genes

- Prior radiotherapy must have been completed 4 weeks before randomization

- Adequate bone marrow, kidney and liver function

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

- Previous chemotherapy for metastatic disease

- Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the
12 months preceding randomization

- Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors

- Clinical or radiographic evidence of brain metastases

- Clinically significant cardiovascular disease or disorder

- History of neoplastic disease other than colorectal cancer in the 3 years prior to
start of study treatment, except for successfully treated non-invasive carcinomas
such as cervical cancer in situ, basal cell carcinoma of the skin or superficial
bladder tumours

- HIV, hepatitis B or C infection

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria

Outcome Time Frame:

up to 4 years

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche


Spain: National Spanish Agency for Medicines and Sanitary Products

Study ID:




Start Date:

June 2011

Completion Date:

May 2015

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms