An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-Free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-Free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- colorectal cancer;
- advanced or recurrent disease;
- >=1 measurable lesion;
- >=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy.
Exclusion Criteria:
- previous treatment for colorectal cancer;
- significant history of cardiac disease in past 6 months;
- other invasive malignancy within past 5 years, except for nonmelanoma skin cancer,
and successfully treated cervical or prostate cancer.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Brazil: Comissao Nacional de Etica em Pesquisa (CONEP)
Study ID:
ML20452
NCT ID:
NCT00577109
Start Date:
Completion Date:
June 2012
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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