A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00069121
First received: September 15, 2003
Last updated: April 15, 2013
Last verified: April 2013
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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:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Capecitabine
U.S. FDA Resources
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: | January 2012 |
| Primary Completion Date: | January 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069121
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| 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 | |
| United States, New Jersey | |
| 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 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| New York, New York, United States, 10011 | |
| Rockville Centre, New York, United States, 11570 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Greensboro, North Carolina, United States, 27401 | |
| Hickory, North Carolina, United States, 28602 | |
| United States, Pennsylvania | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Kingston, Pennsylvania, United States, 18704 | |
| Lancaster, Pennsylvania, United States, 17605 | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29403-5740 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38120 | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| The Woodlands, Texas, United States, 77380 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Washington | |
| 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 | |
| Canada, British Columbia | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Newfoundland and Labrador | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| 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: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Leucovorin Levoleucovorin Oxaliplatin |
Capecitabine Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013