Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT01024504
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles
  • Capecitabine — DRUG
    Capecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles
  • Bevacizumab — DRUG
    Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles

Study Details

This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.

Key Dates

First listed
Dec 2, 2009
Start date
Mar 31, 2006
Status verified
Apr 2010
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XELOX/Avastin
    Capecitabine Oxaliplatin Bevacizumab

Primary Outcome Measure

Overall response rate [ Time Frame: 2 - 4 months ]

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