A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581423
• Other study ID #: ML18601
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2015
• Last updated: November 1, 2016
• Start date: August 2005
• Est. completion date: March 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults at least 18 years of age

• Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry

Exclusion Criteria:

• Macroscopic or microscopic residual tumor

• Evidence of metastatic disease including tumor cells in ascites

• Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer

• Active cardiovascular disease

• Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix

• Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine
Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Up to approximately 6 months	No
Primary	Incidence of treatment discontinuation due to AEs		Up to approximately 6 months	No
Secondary	Incidence of toxocity-related dose reductions		Up to approximately 6 months	No