A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567331
• Other study ID #: ML18017
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2015
• Last updated: November 1, 2016
• Start date: October 2004
• Est. completion date: April 2006

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 efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients greater than or equal to (>=) 18 years of age

• Metastatic colorectal cancer

Exclusion Criteria:

• Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease

• Central nervous system and bone metastases

• Moderate or severe renal impairment

• Clinically significant cardiac disease

• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication

• Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy 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 1250 mg/m^2 capecitabine administered twice daily as oral tablets for 14 days followed by a 7 day rest period for up to 6 treatment cycles.

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		up to approximately 1.5 years	No
Primary	Response rate, ie, percentage of participants with complete, partial, and overall response		up to approximately 1.5 years	No
Secondary	Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n		up to approximately 1.5 years	No