A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00700570
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab [Avastin] — DRUG
    5mg/kg iv on day 1 of each 2 week cycle.
  • capecitabine [Xeloda] — DRUG
    1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle
  • oxaliplatin — DRUG
    85mg/m2 iv on day 1 of each 2 week cycle

Study Details

This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Key Dates

First listed
Jun 18, 2008
Start date
Aug 31, 2008
Status verified
Nov 2016
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases [ Time Frame: After 5 cycles of neoadjuvant treatment (10 weeks) ]

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