A Single-arm Open-label Study on the Effect on Progression-free Survival by Adding Bevacizumab to XELOX Chemotherapy as Treatment Beyond Progression in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Single-arm Open-label Study on the Effect on Progression-free Survival by Adding Bevacizumab to XELOX Chemotherapy as Treatment Beyond Progression in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination
Inclusion Criteria:
- adult patients >/=18 years of age
- metastatic colorectal cancer
- disease progression with prior FOLFIRI+bevacizumab therapy
-
- ECOG
Exclusion Criteria:
- clinically significant cardiovascular disease
- CNS disease except for treated brain metastasis
- history of other malignancies within 2 years prior to start of study treatment (with
the exception of curatively treated basal and squamous cell carcinoma of the skin or
in situ carcinoma of the cervix)
- major surgery, open biopsy, or significant traumatic injury within 28 days prior to
start of study treatment
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:
tumour assessment every 9 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
ML22519
NCT ID:
NCT01077739
Start Date:
July 2009
Completion Date:
January 2012
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
- Disease Progression
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