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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01159171
First received: July 7, 2010
Last updated: March 16, 2012
Last verified: March 2012
History of Changes

July 7, 2010
March 16, 2012
January 2006
December 2011   (final data collection date for primary outcome measure)
Overall response rate (ORR: complete and partial response); tumor assessments by Computer Tomography (CT) scan or by Magnetic Resonance Imaging (MRI) [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01159171 on ClinicalTrials.gov Archive Site
  • Safety: Adverse events, laboratory parameters [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
  • Duration of response (DR); tumor assessments by CT scan or ba MRI [ Time Frame: from response to disease progression ] [ Designated as safety issue: No ]
  • Time to progression (TTP); tumor assessments by CT scan or by MRI [ Time Frame: from baseline to disease progression ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: from baseline to death of any cause ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    5 mg/kg intravenously every 14 days
  • Drug: capecitabine [Xeloda]
    1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle
  • Drug: oxaliplatin
    40 mg/m2 iv weekly
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: capecitabine [Xeloda]
  • Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients >=18 years of age
  • Locally advanced or metastatic colorectal cancer
  • No previous treatment with chemotherapy for metastatic disease
  • Measurable and/or evaluable lesions

Exclusion Criteria:

  • Radiotherapy within 4 weeks before study
  • Untreated brain metastases or primary brain tumors
  • Chronic, daily treatment with high-dose aspirin (>325mg/day)
  • Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01159171
ML18523
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP