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A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 15, 2003
Last updated: November 24, 2014
Last verified: November 2014

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda

, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxali platin) in patients previously treated for metastatic colorectal cancer. Patient s will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Condition Intervention Phase
Colorectal Cancer
Drug: 5 FU
Drug: Leucovorin
Drug: Oxaliplatin
Drug: capecitabine [Xeloda]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to tumor progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, overall response rate, time to response, duration of response, time to treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory outcomes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 627
Study Start Date: May 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Oxaliplatin
As prescribed, in 3 week cycles
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle
Active Comparator: 2 Drug: 5 FU
As prescribed, in 2 week cycles
Drug: Leucovorin
As prescribed, in 2 week cycles
Drug: Oxaliplatin
As prescribed, in 2 week cycles


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00069108

  Hide Study Locations
United States, California
Bakersfield, California, United States, 93304
Los Angeles, California, United States, 90089
Monterey, California, United States, 93940
United States, Colorado
Colorado Springs, Colorado, United States, 80903
United States, District of Columbia
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Miami, Florida, United States, 33133
Miami Beach, Florida, United States, 33140
United States, Indiana
Terre Haute, Indiana, United States, 47802
United States, Iowa
Des Moines, Iowa, United States, 50309
United States, Missouri
St Louis, Missouri, United States, 63136
United States, Montana
Billings, Montana, United States, 59101
Great Falls, Montana, United States, 59405
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, New Jersey
Summit, New Jersey, United States, 07901
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
Nyack, New York, United States, 10960
Rockville Centre, New York, United States, 11570
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18015
Kingston, Pennsylvania, United States, 18704
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
The Woodlands, Texas, United States, 77380
United States, Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Burien, Washington, United States, 98166
Yakima, Washington, United States, 98902
United States, Wisconsin
Wausau, Wisconsin, United States, 54401
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1000
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Mont-godinne, Belgium, 5530
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London, Ontario, Canada, N6A 4L6
Oshawa, Ontario, Canada, L1G 2B9
Ottawa, Ontario, Canada, K1H 8L6
St. Catharines, Ontario, Canada, L2R 7C6
Thunder Bay, Ontario, Canada, P7A 7T1
Toronto, Ontario, Canada, M9N 1N8
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Laval, Quebec, Canada, H7M 3L9
Levis, Quebec, Canada, G6V 3Z1
Montreal, Quebec, Canada, H4J 1C5
Montreal, Quebec, Canada, H2W 1S6
Montreal, Quebec, Canada, H1T 2M4
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4T 7T1
Split, Croatia, 21000
Zagreb, Croatia, 10000
Tampere, Finland, 33520
Turku, Finland, 20520
Avignon, France, 84918
Bordeaux, France, 33076
Bordeaux, France, 33075
Chambray Les Tours, France, 37171
Limoges, France, 87042
Lyon, France, 69008
Nimes, France, 30029
Paris, France, 75908
Pessac, France, 33604
Rouen, France, 76031
Lemgo, Germany, 32657
Trier, Germany, 54290
Tübingen, Germany, 72076
Heraklion, Greece, 71110
Thessaloniki, Greece, 56439
Beer Sheva, Israel, 8410101
Jerusalem, Israel, 91031
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 49100
Ramat-gan, Israel, 52621
Rehovot, Israel, 76100
Tel Aviv, Israel, 6423906
Aviano, Italy, 33081
Bergamo, Italy, 24128
Cattolica, Italy, 47841
Livorno, Italy, 57100
Rimini, Italy, 47900
Udine, Italy, 33100
Korea, Republic of
Buchun, Korea, Republic of, 420-021
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 133-792
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 137-040
Bialystok, Poland, 15-027
Krakow, Poland, 31-501
Warszawa, Poland, 00-909
Warszawa, Poland, 02-781
Puerto Rico
San Juan, Puerto Rico, 00921-3201
Belgrade, Serbia, 11000
Bratislava, Slovakia, 831 01
Ljubljana, Slovenia, 1000
South Africa
Cape Town, South Africa, 7500
Durban, South Africa, 4001
Pietermaritzburg, South Africa, 3201
Port Elizabeth, South Africa, 6045
Pretoria, South Africa, 0001
Barcelona, Spain, 08036
Barcelona, Spain, 08907
Granada, Spain, 18014
Leganes, Spain, 28911
Madrid, Spain, 28222
Madrid, Spain, 28041
Madrid, Spain, 28034
Palma de Mallorca, Spain, 07014
Tainan, Taiwan, 704
Taipei, Taiwan, 104
Taoyuan, Taiwan, 333
United Kingdom
Denbigh, United Kingdom, LL18 5UJ
London, United Kingdom, W12 OHS
London, United Kingdom, SW3 6JJ
Manchester, United Kingdom, M20 4BX
Preston, United Kingdom, PR2 9HT
Sutton, United Kingdom, SM2 5PT
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT00069108     History of Changes
Other Study ID Numbers: NO16967
Study First Received: September 15, 2003
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2014