A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) in Elderly Patients With Metastatic Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00484939
First received: June 11, 2007
Last updated: January 13, 2014
Last verified: January 2014

June 11, 2007
January 13, 2014
July 2007
March 2013   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Progression-free survival
Complete list of historical versions of study NCT00484939 on ClinicalTrials.gov Archive Site
  • Best overall response, duration of response, time to response, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Best overall response, duration of response, time to response, overall survival. Safety: Adverse events, laboratory parameters, vital signs.
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) in Elderly Patients With Metastatic Colorectal Cancer.
A Randomized, Open-label Study to Evaluate the Effect of Avastin in Combination With Xeloda on Progression-free Survival in Elderly Patients With Metastatic Colorectal Cancer

This 2 arm study will assess the efficacy and safety of Avastin in combination with Xeloda, compared with Xeloda alone, in elderly patients with metastatic colorectal cancer. Patients will be randomized to receive either Avastin (7.5mg/kg iv on day 1 of each 3 week cycle), in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3 week cycle), or Xeloda (1000mg/m2 po bid on days 1-14 of each 3 week cycle) alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    7.5mg/kg iv on day 1 of each 3 week cycle
  • Drug: Xeloda
    1000mg/m2 po bid on days 1-14 of each 3 week cycle
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Xeloda
  • Active Comparator: 2
    Intervention: Drug: Xeloda
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=70 years of age
  • cancer of the colon or rectum;
  • metastatic disease diagnosed <=6 months before enrolment;
  • >=1 measurable metastatic lesion.

Exclusion Criteria:

  • adjuvant anti-VEGF treatment;
  • prior chemotherapeutic treatment for metastatic colorectal cancer;
  • past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
  • clinically significant cardiovascular disease;
  • current or recent daily use of aspirin (>325mg/day) or other NSAID, or full dose anticoagulants.
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   Greece,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Slovenia,   Spain,   United Kingdom
 
NCT00484939
MO19286
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2014

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