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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


Phase 3
70 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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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

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