Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205322
• Other study ID #: CO03216
• Secondary ID: M-2003-0544A5342
• Status: Completed
• Phase: Phase 2
• Start date: April 2004
• Est. completion date: October 2007

Study information

• Verified date: December 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients		Bi-monthly collection of information regarding tumor progression and overall survival.
Secondary	Is the oral drug an advantage in this patient population		Bi-monthly collection of information regarding tumor progression and overall survival

External Links

•   University of Wisconsin Carbone Cancer Center