A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01135498
First received: June 1, 2010
Last updated: October 7, 2013
Last verified: October 2013

June 1, 2010
October 7, 2013
November 2006
April 2010   (final data collection date for primary outcome measure)
Progression-free survival\n [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
Progression-free survival (PFS) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01135498 on ClinicalTrials.gov Archive Site
  • Overall response rate (ORR) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Abnormal laboratory values [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.
An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    Intravenous repeating dose
  • Drug: eloxatin
    Intravenous repeating dose
  • Drug: capecitabine [Xeloda]
    Oral repeating dose
  • Drug: erlotinib [Tarceva]
    Oral repeating dose
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: eloxatin
  • Drug: capecitabine [Xeloda]
  • Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • adenocarcinoma of colon or rectum, with metastatic disease;
  • >=1 measurable lesion.

Exclusion Criteria:

  • previous treatment with Avastin or Tarceva;
  • previous systemic treatment for advanced or metastatic disease;
  • adjuvant treatment for non-metastatic disease in past 6 months.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01135498
ML19875
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

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