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OpenTrials
Completed

NCT Number: NCT00048139

A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

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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 2

Primary location

Phoenix, Arizona, United States

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 >=18 years of age;
  • locally advanced and/or metastatic colorectal cancer;
  • >=1 target lesion.

Exclusion criteria

  • previous treatment with Xeloda or irinotecan;
  • previous systemic therapy for metastatic disease;
  • progressive disease during previous adjuvant therapy or within 6 months of completion.

Treatment and study plan

Irinotecan

Drug

250mg/m2 iv on day 1 of each 3 week cycle

capecitabine [Xeloda]

Drug

1000mg/m2 po bid on days 1-15 of each 3 week cycle

Primary outcomes

  1. Tumor measurement (RECIST criteria)

    Time frame: Event driven

Secondary outcomes

  1. Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.

    Time frame: Event driven

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Oct 25, 2002
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.

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