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A Randomized, Open-label Study of the Effect of Intermittent Xeloda Versus iv Fluorouracil/Leucovorin, Both in Combination With Eloxatin, on Tumor Progression in Patients With Metastatic Colorectal Cancer Who Received Prior CPT-11 and 5-fluorouracil/Leucovorin


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

A Randomized, Open-label Study of the Effect of Intermittent Xeloda Versus iv Fluorouracil/Leucovorin, Both in Combination With Eloxatin, on Tumor Progression in Patients With Metastatic Colorectal Cancer Who Received Prior CPT-11 and 5-fluorouracil/Leucovorin


Inclusion Criteria:



- adult patients >=18 years of age;

- metastatic colorectal cancer;

- >=1 target lesion;

- failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

- previous treatment with oxaliplatin;

- progressive or recurrent disease during or within 6 months of completion of
first-line chemotherapy;

- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic
disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to tumor progression

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:

NO16967

NCT ID:

NCT00069108

Start Date:

May 2003

Completion Date:

January 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location
Bettendorf, Iowa  52722
Great Falls, Montana  59405
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Denver, Colorado  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Washington, District of Columbia  
Salt Lake City, Utah  84112