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 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.

Key facts

Study ID

NCT00048139

Run by

Hoffmann-La Roche

People needed

52

Starts

2001-10-01

Expected to finish

2005-06-01

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 — Phoenix, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — La Jolla, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hutchinson, Kansas, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Buffalo, New York, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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