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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor measurement (RECIST criteria)

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

MO16461

NCT ID:

NCT00048139

Start Date:

October 2001

Completion Date:

June 2005

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Phoenix, Arizona  85012
Fountain Valley, California  92708
Albany, New York  12208
Austin, Texas  78705
Kansas City, Kansas  66160
Albuquerque, New Mexico  87131-5636
Denver, Colorado  
Las Vegas, Nevada  89109