A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin

Sponsor
Hoffmann-La Roche
Study ID
NCT01077739
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • fluorouracil (5FU) — DRUG
    standard FOLFOX regimen
  • leucovorin — DRUG
    standard FOLFOX regimen
  • bevacizumab [Avastin] — DRUG
    7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks
  • capecitabine [Xeloda] — DRUG
    standard XELOX regimen
  • oxaliplatin — DRUG
    standard XELOX or FOLFOX regimen

Study Details

This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda \[capecitabine\] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Key Dates

First listed
Mar 1, 2010
Start date
Jul 31, 2009
Status verified
Dec 2014
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
75 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Avastin (bevacizumab) + standard of care

Primary Outcome Measure

Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression [ Time Frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months ]

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