Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Inclusion Criteria:
- Untreated metastatic colorectal carcinoma
- Age 18 yrs or over
- Measurable disease according to Response Evaluation Criteria in solid Tumors
(RECIST criteria)
- ECOG performance status 0 or 1
- Life expectancy more than 3 months
- Adequate haematological, renal and liver function
- Tumor tissue available for determination of KRAS mutational status
- Blood sample and paraffin embedded tumor tissue for translational research
Exclusion Criteria:
- Adjuvant therapy within 6 months
- CNS metastases
- Clinically significant atherosclerotic vascular disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab.
Outcome Time Frame:
3 years
Safety Issue:
Yes
Authority:
Sweden: Medical Products Agency
Study ID:
ML 25359
NCT ID:
NCT01229813
Start Date:
October 2010
Completion Date:
Related Keywords:
- Colorectal Cancer
- Untreated
- First line
- Chemotherapy
- Maintenance treatment
- KRAS wt
- KRAS mutated
- Anti-angiogenetic treatment
- Metronomic capecitabine
- bevacizumab
- erlotinib
- Translational research
- Colorectal Neoplasms
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