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

November 1, 2016 updated by: Hoffmann-La Roche

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years
Response rate, ie, percentage of participants with complete, partial, and overall response
Time Frame: up to approximately 1.5 years
up to approximately 1.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • ML18017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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