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

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous 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.

Key facts

Study ID

NCT00048126

Run by

Hoffmann-La Roche

People needed

57

Starts

2001-07-01

Expected to finish

2005-01-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — La Jolla, California, United States
• Study site — Miami, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Providence, Rhode Island, United States
• Study site — Memphis, Tennessee, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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