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

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ClinicalTrials.gov Identifier: NCT00205322
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer
Study Start Date : April 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients [ Time Frame: Bi-monthly collection of information regarding tumor progression and overall survival. ]

Secondary Outcome Measures :
  1. Is the oral drug an advantage in this patient population [ Time Frame: Bi-monthly collection of information regarding tumor progression and overall survival ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205322


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Daniel Mulkerin, MD University of Wisconsin, Madison
More Information
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Additional Information:
University of Wisconsin Carbone Cancer Center  This link exits the ClinicalTrials.gov site

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205322     History of Changes
Other Study ID Numbers: CO03216
M-2003-0544 ( Other Identifier: Institutional Review Board )
A534260 ( Other Identifier: UW Madison )
SMPH/MEDICINE/H ( Other Identifier: UW Madison )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: December 2011
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents