Trial record 1 of 1 for:    NO16968
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A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00069121
First received: September 15, 2003
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 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: capecitabine [Xeloda]
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5 FU
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 in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-free Survival in Patients Who Have Undergone Surgery for Colon Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease-free Survival (DFS) [Number of Events] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ] [ Designated as safety issue: No ]
    Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.

  • Disease-free Survival [Time to Event] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ] [ Designated as safety issue: No ]
    Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.


Secondary Outcome Measures:
  • Relapse-free Survival (RFS) [Number of Events] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ] [ Designated as safety issue: No ]
    Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.

  • Relapse-free Survival (RFS) [Time to Event] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ] [ Designated as safety issue: No ]
    Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.

  • Overall Survival [Number of Events] [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ] [ Designated as safety issue: No ]
    Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.

  • Overall Survival [Time to Event] [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ] [ Designated as safety issue: No ]
    Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.

  • Number of Participants Assesed for Adverse Events [ Time Frame: followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake ] [ Designated as safety issue: No ]

    Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.

    See Adverse Events module for details.



Enrollment: 1886
Study Start Date: January 2003
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
1000mg/m2 iv bid on days 1-15 of each 3 week cycle
Drug: Oxaliplatin
As prescribed, in 3 week cycles
Active Comparator: 2 Drug: Oxaliplatin
As prescribed, in 2 week cycles
Drug: Leucovorin
As prescribed, in 2 week cycles.
Drug: 5 FU
As prescribed, in 2 week cycles

  Eligibility

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

Inclusion Criteria:

  • adult patients >=18 years of age;
  • colon cancer;
  • complete tumor resection.

Exclusion Criteria:

  • prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.
  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 ClinicalTrials.gov identifier: NCT00069121

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Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Tucson, Arizona, United States, 85723
Tucson, Arizona, United States, 85724
United States, California
Alhambra, California, United States, 91801
Bakersfield, California, United States, 93309
Fresno, California, United States, 93710
Fullerton, California, United States, 92835
Long Beach, California, United States, 90813-3244
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90095
Los Angeles, California, United States, 90033
Northridge, California, United States, 91325
Oxnard, California, United States, 93030
Pomona, California, United States, 91767
Porterville, California, United States, 93257
Redondo Beach, California, United States, 90277
Sacramento, California, United States, 95816
San Diego, California, United States, 92121
San Diego, California, United States, 92154
Santa Barbara, California, United States, 93105
Vista, California, United States, 92083
United States, Colorado
Denver, Colorado, United States, 80262
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Stamford, Connecticut, United States, 06902
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Fort Lauderdale, Florida, United States, 33308
Lakeland, Florida, United States, 33805
Miami, Florida, United States, 33136
Tampa, Florida, United States, 33612-9497
United States, Georgia
Atlanta, Georgia, United States, 30341
United States, Idaho
Coeur D'alene, Idaho, United States, 83814
United States, Illinois
Peoria, Illinois, United States, 61615-7828
United States, Indiana
Terre Haute, Indiana, United States, 47802
United States, Iowa
Des Moines, Iowa, United States, 50309
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
St Louis Park, Minnesota, United States, 55416
United States, Missouri
St Joseph, Missouri, United States, 64507
St Louis, Missouri, United States, 63136
United States, Montana
Billings, Montana, United States, 59101
Great Falls, Montana, United States, 59405
United States, Nevada
Las Vegas, Nevada, United States, 89169
Reno, Nevada, United States, 89502
United States, New Hampshire
Concord, New Hampshire, United States, 03301
Hooksett, New Hampshire, United States, 03106
Lebanon, New Hampshire, United States, 03756
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Morristown, New Jersey, United States, 07962
New Brunswick, New Jersey, United States, 08901
Paramus, New Jersey, United States, 07652
Summit, New Jersey, United States, 07901
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Albuquerque, New Mexico, United States, 87109
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New York, New York, United States, 10011
Rockville Centre, New York, United States, 11570
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Charlotte, North Carolina, United States, 28233-3549
Greensboro, North Carolina, United States, 27401
Hickory, North Carolina, United States, 28602
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Bethlehem, Pennsylvania, United States, 18015
Kingston, Pennsylvania, United States, 18704
Lancaster, Pennsylvania, United States, 17605
Philadelphia, Pennsylvania, United States, 19104-4283
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Pittsburgh, Pennsylvania, United States, 15232
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Charleston, South Carolina, United States, 29403-5740
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Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37232
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The Woodlands, Texas, United States, 77380
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Salt Lake City, Utah, United States, 84106
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Burien, Washington, United States, 98166
Puyallup, Washington, United States, 98372
Yakima, Washington, United States, 98902
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Australia
Adelaide, Australia, 5011
Camperdown, Australia, 2050
Melbourne, Australia, 3128
Perth, Australia, 6008
Port Macquarie, Australia, 2444
Wollongong, Australia, 2500
Belgium
Brussels, Belgium, 1200
Charleroi, Belgium, 6000
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Brazil
Belo Horizonte, Brazil, 30285-000
JAU, Brazil, 17210-080
Sao Paulo, Brazil, 05403-000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T5J 3N4
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Kelowna, British Columbia, Canada, V1Y 5L3
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Winnipeg, Manitoba, Canada, R2H 2A6
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Hamilton, Ontario, Canada, L8V 5C2
London, Ontario, Canada, N6A 4L6
Mississauga, Ontario, Canada, L5M 2N1
Oshawa, Ontario, Canada, L1G 2B9
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M9N 1N8
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Laval, Quebec, Canada, H7M 3L9
Levis, Quebec, Canada, G6V 3Z1
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H3T 1E2
Montreal, Quebec, Canada, H4J 1C5
Montreal, Quebec, Canada, H1T 2M4
Quebec City, Quebec, Canada, G1R 2J6
China
Beijing, China, 100021
Guangdong, China, 510515
Hangzhou, China, 310009
Jiangsu, China, 210009
Jiangxi, China, 330000
Shandong, China, 250117
Shanghai, China, 200092
Shanghai, China, 200025
Shanghai, China, 200032
Tianjin, China, 300060
Wuhan, China, 430030
Finland
Tampere, Finland, 36280
Turku, Finland, 20521
France
Colmar, France, 68024
Lille, France, 59037
Marseille, France, 13273
Strasbourg, France, 67098
Germany
Freiburg, Germany, 79117
Halle, Germany, 06120
Magdeburg, Germany, 39130
Trier, Germany, 54290
Greece
Athens, Greece, 11527
Athens, Greece, 10676
Heraklion, Greece, 71110
Patras, Greece, 26500
Thessaloniki, Greece, 56439
Thessaloniki, Greece, 54007
Hong Kong
Hong Kong, Hong Kong, 852
Hungary
Budapest, Hungary, 1122
Budapest, Hungary, 1097
Debrecen, Hungary, 4012
Szeged, Hungary, 6720
Ireland
Cork, Ireland
Dublin, Ireland, 4
Dublin, Ireland, 8
Galway, Ireland
Israel
Beer Sheva, Israel, 84101
Haifa, Israel, 31096
Jerusalem, Israel, 91031
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Petach Tikva, Israel, 49100
Petach Tikva, Israel
Ramat Gan, Israel, 52621
Rehovot, Israel, 76100
Tel Aviv, Israel, 64239
Zerifin, Israel, 70300
Italy
Ancona, Italy, 60121
Bergamo, Italy, 24128
Cattolica, Italy, 47841
Genova, Italy, 16132
Livorno, Italy, 57100
Milano, Italy, 20141
Parma, Italy, 43100
Rimini, Italy, 47900
Sassari, Italy, 07100
Siena, Italy, 53100
Udine, Italy, 33100
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-170
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 133-792
Mexico
Chihuahua, Mexico, 31000
Mexicali, Mexico, 21100
Mexico City, Mexico, 31000
Mexico City, Mexico, 03100
Mexico City, Mexico, 14000
New Zealand
Auckland, New Zealand, 1009
Christchurch, New Zealand
Dunedin, New Zealand, 9001
Palmerston North, New Zealand
Wellington, New Zealand, 6002
Panama
Panama City, Panama
Poland
Krakow, Poland, 31-826
Lodz, Poland, 93-509
Poznan, Poland, 61-866
Szczecin, Poland, 71-730
Warszawa, Poland, 02-781
Zielona Gora, Poland, 65-046
Portugal
Beja, Portugal, 7801-849
Lisboa, Portugal, 1649-035
Porto, Portugal, 4200
Russian Federation
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 105229
St Petersburg, Russian Federation, 198255
St Petersburg, Russian Federation, 197758
Singapore
Singapore, Singapore, 169610
Singapore, Singapore, 119228
South Africa
Cape Town, South Africa, 7500
Durban, South Africa, 4001
Pietermaritzburg, South Africa, 3201
Pretoria, South Africa, 0001
Sandton, South Africa, 2199
Spain
Barakaldo, Spain, 48903
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Córdoba, Spain, 14004
Elche, Spain, 03202
Jaen, Spain, 23007
Leganes, Spain, 28911
Madrid, Spain, 28046
Madrid, Spain, 28040
Madrid, Spain, 28222
Madrid, Spain, 28006
Madrid, Spain, 28041
Malaga, Spain, 29010
Palma de Mallorca, Spain, 07014
Pamplona, Spain, 31008
Santander, Spain, 39008
Valencia, Spain, 46010
Valencia, Spain, 46009
Switzerland
Basel, Switzerland, 4031
Taiwan
Taipei, Taiwan
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10700
Bangkok, Thailand, 10400
Bangkok, Thailand, 10110
Khon Kaen, Thailand, 40002
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Belfast, United Kingdom, BT9 7AB
Brighton, United Kingdom, BN2 5BE
Bury St Edmunds, United Kingdom, IP33 2QZ
Cambridge, United Kingdom, CB2 2QH
Denbigh, United Kingdom, LL18 5UJ
Derby, United Kingdom, DE1 2QY
Glasgow, United Kingdom, G12 0YN
Guildford, United Kingdom, GU2 5XX
Hull, United Kingdom, HU8 9HE
Leeds, United Kingdom, LS9 7TF
Leicester, United Kingdom, LE1 5WW
London, United Kingdom, W6 8RF
London, United Kingdom, SW3 6JJ
London, United Kingdom, SE1 7EH
London, United Kingdom, W12 OHS
Maidstone, United Kingdom, ME16 9QQ
Manchester, United Kingdom, M20 4BX
Middlesborough, United Kingdom, TS4 3BW
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Northwood, United Kingdom, HA6 2RN
Nottingham, United Kingdom, NG5 1PB
Plymouth, United Kingdom, PL6 8DH
Salisbury, United Kingdom, SP2 8BJ
Southampton, United Kingdom, SO16 6YD
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069121     History of Changes
Obsolete Identifiers: NCT00080691
Other Study ID Numbers: NO16968
Study First Received: September 15, 2003
Results First Received: March 31, 2011
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014