A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
NCT02582970 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2017-03-09
Summary
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
Conditions
Interventions
- DRUG
-
Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
- DRUG
-
Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
- DRUG
-
Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
- DRUG
-
Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2007-10-31
- Completion
- 2008-04-30
Countries
- Taiwan
Study Locations
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