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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4004
  • Sofia, Bulgaria, 1756
  • Sofia, Bulgaria, 1784
  • Sofia, Bulgaria, 1527
  • Stara Zagora, Bulgaria, 8000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capecitabine; Participants will receive oral capecitabine 1250 milligrams per square meter (mg/m^2) twice daily for 14 days followed by 7 day rest period for 6 cycles.	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.; Other Names: Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	up to approximately 1.5 years
Response rate, ie, percentage of participants with complete, partial, and overall response	up to approximately 1.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n	up to approximately 1.5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: ML18017