A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502671
First received: July 17, 2007
Last updated: August 6, 2015
Last verified: August 2015

July 17, 2007
August 6, 2015
July 2007
March 2012   (final data collection date for primary outcome measure)
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE [ Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up) ] [ Designated as safety issue: No ]
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
Serious adverse events, AEs, laboratory abnormalities.
Complete list of historical versions of study NCT00502671 on ClinicalTrials.gov Archive Site
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE [ Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up) ] [ Designated as safety issue: No ]
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
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A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 of each 3 week cycle
Experimental: 1
Intervention: 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
228
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • colon cancer (Dukes stage C);
  • surgery, with no evidence of remaining tumor;
  • ECOG performance status of <=1.

Exclusion Criteria:

  • previous therapy for currently treated colon cancer;
  • any evidence of metastatic disease;
  • history of other malignancy within last 5 years;
  • clinically significant cardiac disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00502671
ML20592
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2015

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