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A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048139
First received: October 24, 2002
Last updated: November 3, 2014
Last verified: November 2014

October 24, 2002
November 3, 2014
October 2001
June 2005   (final data collection date for primary outcome measure)
Tumor measurement (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00048139 on ClinicalTrials.gov Archive Site
Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer

This study will assess the efficacy and safety of intermittent oral Xeloda admin istration in combination with irinotecan as a first-line treatment in patients w ith advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: capecitabine [Xeloda]
    1000mg/m2 po bid on days 1-15 of each 3 week cycle
  • Drug: Irinotecan
    250mg/m2 iv on day 1 of each 3 week cycle
Experimental: 1
Interventions:
  • Drug: capecitabine [Xeloda]
  • Drug: Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients >=18 years of age;
  • locally advanced and/or metastatic colorectal cancer;
  • >=1 target lesion.

Exclusion Criteria:

  • previous treatment with Xeloda or irinotecan;
  • previous systemic therapy for metastatic disease;
  • progressive disease during previous adjuvant therapy or within 6 months of completion.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00048139
MO16461
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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