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A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer


Inclusion Criteria:



- no prior treatment for metastatic disease

- PS 0-2

- measurable disease

Exclusion Criteria:

- neuropathy > or equal to grade 2

- concomitant radiation therapy or other systemic cancer therapies

- brain mets

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:

Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients

Outcome Time Frame:

Bi-monthly collection of information regarding tumor progression and overall survival.

Safety Issue:

No

Principal Investigator

Daniel Mulkerin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

M-2003-0544 (CO03216)

NCT ID:

NCT00205322

Start Date:

April 2004

Completion Date:

October 2007

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

University of WisconsinMadison,, Wisconsin  53792-5666