A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT01159171
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    5 mg/kg intravenously every 14 days
  • capecitabine [Xeloda] — DRUG
    1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle
  • oxaliplatin — DRUG
    40 mg/m2 iv weekly

Study Details

This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.

Key Dates

First listed
Jul 9, 2010
Start date
Jan 31, 2006
Status verified
Jul 2014
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]

Related Studies