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Trial record 53 of 441 for:    colon cancer AND Capecitabine AND colon cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE April 2004
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2011)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients
Change History Complete list of historical versions of study NCT00205322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2011)
Is the oral drug an advantage in this patient population [ Time Frame: Bi-monthly collection of information regarding tumor progression and overall survival ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Is the oral drug an advantage in this patient population
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer
Official Title  ICMJE A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE Drug: chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
45
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00205322
Other Study ID Numbers  ICMJE CO03216
M-2003-0544 ( Other Identifier: Institutional Review Board )
A534260 ( Other Identifier: UW Madison )
SMPH/MEDICINE/H ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Mulkerin, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP