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A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.

NCT00349336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2012-09-18

Study results available
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Summary

This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

Interventions

DRUG

bevacizumab [Avastin]

7.5mg/kg iv on day 1 of each 3 week cycle

DRUG

XELOX

As prescribed

DRUG

bevacizumab [Avastin]

5mg/kg iv on day 1 of each 2 week cycle

DRUG

FOLFOX-4

As prescribed

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00349336 on ClinicalTrials.gov