Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients.

Sponsor
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study ID
NCT01067053
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • bevacizumab, capecitabine, oxaliplatin — DRUG
    6 cycles (3 weeks each one) of: * bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle. * capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks. * oxaliplatin: 130/mg/m2(iv),1st day of each cycle. After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine

Study Details

The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin are an effective and safe first line of treatment for elderly patients with metastatic colorectal adenocarcinoma.

Key Dates

First listed
Feb 11, 2010
Start date
Nov 30, 2009
Status verified
Jan 2014
Primary completion
Nov 30, 2010
Completion
Mar 31, 2014

Study Design

Enrollment
69 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab, capecitabine, oxaliplatin
    6 cycles (3 weeks each one) of: * bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle. * capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks. * oxaliplatin: 130/mg/m2(iv),1st day of each cycle. After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine

Primary Outcome Measure

Time to progression [ Time Frame: 3 years ]

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