Skip to main content
OpenTrials
Completed

NCT Number: NCT02567331

A Study of Capecitabine (Xeloda) in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Plovdiv, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: up to approximately 1.5 years

  2. Response rate, ie, percentage of participants with complete, partial, and overall response

    Time frame: up to approximately 1.5 years

Secondary outcomes

  1. Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n

    Time frame: up to approximately 1.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Oct 2, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.