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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00069121 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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.2 |
| Estimated Enrollment: | 1886 |
| Study Start Date: | May 1905 |
| Estimated Study Completion Date: | December 2011 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: capecitabine [Xeloda]
1000mg/m2 iv bid on days 1-15 of each 3 week cycle
Drug: Oxaliplatin
As prescribed, in 3 week cycles
|
| 2: Active Comparator |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
| Sacramento, California, United States, 95816 | |
| San Diego, California, United States, 92121 | |
| San Diego, California, United States, 92154 | |
| Los Angeles, California, United States, 90095 | |
| Bakersfield, California, United States, 93309 | |
| Santa Barbara, California, United States, 93105 | |
| Fullerton, California, United States, 92835 | |
| Pomona, California, United States, 91767 | |
| Alhambra, California, United States, 91801 | |
| Oxnard, California, United States, 93030 | |
| Porterville, California, United States, 93257 | |
| Redondo Beach, California, United States, 90277 | |
| Fresno, California, United States, 93710 | |
| Santa Barbara, California, United States, 93105 | |
| Vista, California, United States, 92083 | |
| Northridge, California, United States, 91328 | |
| Long Beach, California, United States, 90813-3244 | |
| Los Angeles, California, United States, 90057 | |
| Los Angeles, California, United States, 90033 | |
| United States, Colorado | |
| Fort Collins, Colorado, United States, 80528 | |
| Denver, Colorado, United States, 80262 | |
| 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 | |
| Lakeland, Florida, United States, 33805 | |
| Tampa, Florida, United States, 33612 | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Miami, Florida, United States, 33136 | |
| 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 | |
| Great Falls, Montana, United States, 59405 | |
| Billings, Montana, United States, 59101 | |
| United States, Nevada | |
| Reno, Nevada, United States, 89502 | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Hampshire | |
| Hooksett, New Hampshire, United States, 03106 | |
| Lebanon, New Hampshire, United States, 03756 | |
| Concord, New Hampshire, United States, 03301 | |
| United States, New Jersey | |
| Paramus, New Jersey, United States, 07652 | |
| Morristown, New Jersey, United States, 07960 | |
| Summit, New Jersey, United States, 07901 | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Rockville Centre, New York, United States, 11570 | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Hickory, North Carolina, United States, 28602 | |
| Greensboro, North Carolina, United States, 27401 | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, Pennsylvania | |
| Lancaster, Pennsylvania, United States, 17605 | |
| Kingston, Pennsylvania, United States, 18704 | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| 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 | |
| Nashville, Tennessee, United States, 37232 | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Fort Worth, Texas, United States, 76177 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Washington | |
| Yakima, Washington, United States, 98902 | |
| Puyallup, Washington, United States, 98372 | |
| Burien, Washington, United States, 98166 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Australia | |
| Melbourne, Australia, 3128 | |
| Sydney, Australia, 2050 | |
| Port Macquarie, Australia, 2444 | |
| Perth, Australia, 6008 | |
| Adelaide, Australia, 5011 | |
| Footscray, Australia, 3011 | |
| Wollongong, Australia, 2500 | |
| Belgium | |
| Leuven, Belgium, 3000 | |
| Gent, Belgium, 9000 | |
| Charleroi, Belgium, 6000 | |
| Kortrijk, Belgium, 8500 | |
| Bruxelles, Belgium, 1200 | |
| Brazil | |
| Sao Paulo, Brazil, 05403-000 | |
| Jaú, Brazil, 17210-080 | |
| Belo Horizonte, Brazil, 30285-000 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| 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 1V7 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto, Ontario, Canada, M9N 1N8 | |
| London, Ontario, Canada, N6A 4L6 | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Canada, Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Laval, Quebec, Canada, H7M 3L9 | |
| China | |
| Shanghai, China, 200092 | |
| Shanghai, China, 200025 | |
| Wuhan, China, 430030 | |
| Beijing, China, 100021 | |
| Jiangxi, China, 330000 | |
| Guangdong, China, 510515 | |
| Jiangsu, China, 210009 | |
| Shandong, China, 250117 | |
| Tianjin, China, 300060 | |
| Hangzhou, China, 310009 | |
| Shanghai, China, 200032 | |
| Finland | |
| Turku, Finland, 20520 | |
| Tampere, Finland, 33520 | |
| France | |
| Strasbourg, France, 67091 | |
| Marseille, France, 13273 | |
| Colmar, France, 68024 | |
| Lille, France, 59037 | |
| Germany | |
| Magdeburg, Germany, 39130 | |
| Halle, Germany, 06120 | |
| Freiburg, Germany, 79117 | |
| Trier, Germany, 54290 | |
| Greece | |
| Heraklion, Greece, 71110 | |
| Patras, Greece, 26500 | |
| Athens, Greece, 10676 | |
| Thessaloniki, Greece, 56439 | |
| Athens, Greece, 11527 | |
| Thessaloniki, Greece, 54007 | |
| Hong Kong | |
| Hong Kong, Hong Kong, 852 | |
| Hungary | |
| Budapest, Hungary, 1122 | |
| Szeged, Hungary, 6720 | |
| Debrecen, Hungary, 4032 | |
| Budapest, Hungary, 1097 | |
| Ireland | |
| Cork, Ireland | |
| Galway, Ireland | |
| Dublin, Ireland, 8 | |
| Dublin, Ireland, 4 | |
| Israel | |
| Tel Aviv, Israel, 64239 | |
| Petach Tikva, Israel, 49100 | |
| Jerusalem, Israel, 91120 | |
| Rehovot, Israel, 76100 | |
| Ramat Gan, Israel, 52621 | |
| Jerusalem, Israel, 91031 | |
| Haifa, Israel, 31096 | |
| Beer Sheva, Israel, 84101 | |
| Nahariya, Israel, 22100 | |
| Petach Tikva, Israel | |
| Zerifin, Israel, 70300 | |
| Kfar Saba, Israel, 44281 | |
| Italy | |
| Cattolica, Italy, 47841 | |
| Milano, Italy, 20141 | |
| Sassari, Italy, 07100 | |
| Rimini, Italy, 47037 | |
| Genova, Italy, 16132 | |
| Livorno, Italy, 57100 | |
| Parma, Italy, 43100 | |
| Ancona, Italy, 60121 | |
| Udine, Italy, 33100 | |
| Genova, Italy, 16132 | |
| Bergamo, Italy, 24128 | |
| Siena, Italy, 53100 | |
| 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 | |
| Mexico City, Mexico, 31000 | |
| Mexico City, Mexico, 14000 | |
| Mexicali, Mexico, 21100 | |
| Mexico City, Mexico, 03100 | |
| Chihuahua, Mexico, 31000 | |
| Mexico City, Mexico, 14000 | |
| New Zealand | |
| Auckland, New Zealand | |
| Palmerston North, New Zealand | |
| Wellington, New Zealand, 6002 | |
| Christchurch, New Zealand | |
| Dunedin, New Zealand, 9001 | |
| Panama | |
| Panama City, Panama | |
| Poland | |
| Szczecin, Poland, 71-730 | |
| Krakow, Poland, 31-826 | |
| Warszawa, Poland, 02-781 | |
| Lodz, Poland, 93-509 | |
| Zielona Gora, Poland, 65-046 | |
| Poznan, Poland, 61-866 | |
| Portugal | |
| Lisboa, Portugal, 1649-035 | |
| Porto, Portugal, 4200 | |
| Beja, Portugal, 7801-849 | |
| Russian Federation | |
| Moscow, Russian Federation, 115478 | |
| St Petersburg, Russian Federation, 198255 | |
| St Petersburg, Russian Federation, 197758 | |
| Moscow, Russian Federation, 105229 | |
| Singapore | |
| Singapore, Singapore, 169610 | |
| Singapore, Singapore, 119074 | |
| South Africa | |
| Sandton, South Africa, 2196 | |
| Pretoria, South Africa, 0001 | |
| Durban, South Africa, 4001 | |
| Cape Town, South Africa, 7500 | |
| Pietermaritzburg, South Africa, 3201 | |
| Spain | |
| Madrid, Spain, 28040 | |
| Barcelona, Spain, 08035 | |
| Valencia, Spain, 46009 | |
| Santander, Spain, 39008 | |
| Elche, Spain, 03202 | |
| Jaen, Spain, 23007 | |
| Barakaldo, Spain, 48903 | |
| Malaga, Spain, 29010 | |
| Madrid, Spain, 28007 | |
| Madrid, Spain, 28041 | |
| Valencia, Spain, 46010 | |
| Córdoba, Spain, 14004 | |
| Barcelona, Spain, 08907 | |
| Madrid, Spain, 28222 | |
| Madrid, Spain, 28046 | |
| Madrid, Spain, 28002 | |
| Palma de Mallorca, Spain, 07014 | |
| Barcelona, Spain, 08036 | |
| Pamplona, Spain, 31008 | |
| Leganes, Spain, 28911 | |
| Switzerland | |
| Basel, Switzerland, 4031 | |
| Taiwan | |
| Taipei, Taiwan | |
| Taipei, Taiwan, 112 | |
| Taoyuan, Taiwan, 333 | |
| Thailand | |
| Bangkok, Thailand, 10700 | |
| Bangkok, Thailand, 10400 | |
| Khon Kaen, Thailand, 40002 | |
| Bangkok, Thailand, 10110 | |
| United Kingdom | |
| Manchester, United Kingdom, M20 4BX | |
| Guildford, United Kingdom, GU2 5XX | |
| Sutton, United Kingdom, SM2 5PT | |
| London, United Kingdom, SW3 6JJ | |
| Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
| Glasgow, United Kingdom, G12 0YN | |
| Northwood, United Kingdom, HA6 2RN | |
| Leicester, United Kingdom, LE1 5WW | |
| Southampton, United Kingdom, SO16 6YD | |
| London, United Kingdom, SE1 7EH | |
| Bury St Edmunds, United Kingdom, IP33 2QZ | |
| Plymouth, United Kingdom, PL6 8DH | |
| Derby, United Kingdom, DE1 2QY | |
| Salisbury, United Kingdom, SP2 8BJ | |
| Maidstone, United Kingdom, ME16 9QQ | |
| Cambridge, United Kingdom, CB2 2QH | |
| Belfast, United Kingdom, BT9 7AB | |
| Nottingham, United Kingdom, NG5 1PB | |
| Leeds, United Kingdom, LS9 7TF | |
| Hull, United Kingdom, HU8 9HE | |
| London, United Kingdom, W12 OHS | |
| Denbigh, United Kingdom, LL18 5UJ | |
| Middlesborough, United Kingdom, TS4 3BW | |
| London, United Kingdom, W6 8RF | |
| Brighton, United Kingdom, BN2 5BE | |
| Aberdeen, United Kingdom, AB25 2ZN | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche ( Disclosures Group ) |
| Study ID Numbers: | NO16968 |
| Study First Received: | September 15, 2003 |
| Last Updated: | November 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00069121 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Capecitabine Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |
