Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Hungary: Ministry of Health
Study ID:
MO19286
NCT ID:
NCT00484939
Start Date:
July 2007
Completion Date:
March 2013
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms