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:
NCT00048126
First received: October 24, 2002
Last updated: September 22, 2014
Last verified: September 2014

October 24, 2002
September 22, 2014
July 2001
January 2005   (final data collection date for primary outcome measure)
Tumor measurements (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00048126 on ClinicalTrials.gov Archive Site
Time to progression, time to response, duration of response, time to treatment failure, survival.\n [ 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 Continuous Xeloda Therapy 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 continuous oral Xeloda adminis tration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individua ls.

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: Irinotecan
    100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.
  • Drug: capecitabine [Xeloda]
    1000mg po bid
Experimental: 1
Interventions:
  • Drug: Irinotecan
  • Drug: capecitabine [Xeloda]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
January 2005
January 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
 
NCT00048126
MO16460
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

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