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An Open Label Study to Assess the Resection Rate of Liver Metastases Following Neoadjuvant Therapy With Avastin in Combination With Oxaliplatin and Capecitabine (XELOX) in Patients With Metastatic Colorectal Cancer With Unresectable Liver Metastasis


Phase 2
N/A
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

An Open Label Study to Assess the Resection Rate of Liver Metastases Following Neoadjuvant Therapy With Avastin in Combination With Oxaliplatin and Capecitabine (XELOX) in Patients With Metastatic Colorectal Cancer With Unresectable Liver Metastasis


Inclusion Criteria:



- adult patients, <=75 years of age;

- chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;

- >=1 measurable lesion;

- ECOG status 0-2.

Exclusion Criteria:

- prior exposure to Avastin;

- clinical or radiological evidence of CNS metastases;

- uncontrolled hypertension, or clinically significant cardiovascular disease;

- ongoing treatment with aspirin (>325mg/day) or other medications known to predispose
to gastrointestinal ulceration.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Resection of liver metastasis after neoadjuvant treatment

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Taiwan: Department of Health

Study ID:

ML21209

NCT ID:

NCT00700570

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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