A Multi-center, Open-label Clinical Trial to Evaluate the Objective Response Rate of Bevacizumab in Combination With Modified FOLFOX-6 Followed by One Year of Maintenance With Bevacizumab Alone in Patients With Initially Not or Borderline Resectable Colorectal Liver Metastases (The CLMO-001 Trial)
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Multi-center, Open-label Clinical Trial to Evaluate the Objective Response Rate of Bevacizumab in Combination With Modified FOLFOX-6 Followed by One Year of Maintenance With Bevacizumab Alone in Patients With Initially Not or Borderline Resectable Colorectal Liver Metastases (The CLMO-001 Trial)
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Adenocarcinoma of the colon or the rectum
- Metastatic disease confined to the liver
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- No previous chemotherapy for metastatic disease or treatment with drugs targeting
VEGF or EGFR
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Presence of metastases outside of the liver
- Radiotherapy within 4 weeks before study start
- History of inflammatory bowel disease
- Presence of serious non-healing wound or ulcer
- Uncontrolled hypertension
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:
Objective response rate
Outcome Time Frame:
Up to 11 two-weeks cycles of treatment
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML25625
NCT ID:
NCT01383707
Start Date:
August 2011
Completion Date:
September 2015
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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