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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00009737 |
Purpose
This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-FU 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: capecitabine [Xeloda] 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 Comparing Adjuvant Chemotherapy With Xeloda, or 5-Fluorouracil Plus Leucovorin, on Disease-Free and Overall Survival in Patients Who Have Had Surgery for Colon Cancer |
| Enrollment: | 3348 |
| Study Completion Date: | March 2008 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 every 21 days.
|
| 2: Active Comparator |
Drug: Leucovorin
20mg/m2 iv daily from day 1 to day 5 every 28 days.
Drug: 5-FU
425mg/m2 iv daily from day 1 to day 5 every 28 days.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| BIRMINGHAM, Alabama, United States, 35294 | |
| United States, Arizona | |
| PHOENIX, Arizona, United States, 85012 | |
| United States, California | |
| Fountain Valley, California, United States, 92708 | |
| LOS ANGELES, California, United States, 90033 | |
| United States, Connecticut | |
| HARTFORD, Connecticut, United States, 06102-5037 | |
| United States, Florida | |
| MIAMI, Florida, United States, 33176 | |
| United States, Georgia | |
| DECATUR, Georgia, United States, 30033 | |
| United States, Missouri | |
| COLUMBIA, Missouri, United States, 65203 | |
| ST LOUIS, Missouri, United States, 63141 | |
| United States, New York | |
| BUFFALO, New York, United States, 14263 | |
| ALBANY, New York, United States, 12208 | |
| United States, Ohio | |
| CLEVELAND, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| PHILADELPHIA, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| NASHVILLE, Tennessee, United States, 37203-1632 | |
| United States, Texas | |
| TYLER, Texas, United States, 75701 | |
| AUSTIN, Texas, United States, 78705 | |
| United States, Washington | |
| SEATTLE, Washington, United States, 98195 | |
| Argentina | |
| BUENOS AIRES, Argentina, C1264AAA | |
| BUENOS AIRES, Argentina, C1270AAE | |
| BUENOS AIRES, Argentina, 1425 | |
| BUENOS AIRES, Argentina, 1417 | |
| Australia | |
| PERTH, Australia, 6000 | |
| BRISBANE, Australia, 4006 | |
| MELBOURNE, Australia, 3128 | |
| SYDNEY, Australia, 2217 | |
| PORT MACQUARIE, Australia, 2444 | |
| ADELAIDE, Australia, 5011 | |
| WODONGA, Australia, 3690 | |
| BENDIGO, Australia, 3552 | |
| ST. LEONARDS, Australia, 2065 | |
| MELBOURNE, Australia, 3181 | |
| ADELAIDE, Australia, 5005 | |
| FITZROY, Australia, 3065 | |
| Austria | |
| INNSBRUCK, Austria, 6020 | |
| WIEN, Austria, 1100 | |
| WIEN, Austria, 1090 | |
| WIEN, Austria, 1030 | |
| KLAGENFURT, Austria, 9026 | |
| OBERWART, Austria, 7400 | |
| ST PÖLTEN, Austria, 3100 | |
| WIEN, Austria, 1220 | |
| WIEN, Austria, 1160 | |
| HALL IN TIROL, Austria, 6060 | |
| LINZ, Austria, 4010 | |
| Belgium | |
| BRUXELLES, Belgium, 1090 | |
| Brazil | |
| SAO PAULO, Brazil, 01406-100 | |
| SOROCABA, Brazil, 18030-510 | |
| RIO DE JANEIRO, Brazil, 20220-410 | |
| PORTO ALEGRE, Brazil, 90020-090 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| KELOWNA, British Columbia, Canada, V1Y 5L3 | |
| Canada, Manitoba | |
| WINNIPEG, Manitoba, Canada, R2H 2A6 | |
| Canada, Ontario | |
| OTTAWA, Ontario, Canada, K1H 1C4 | |
| Canada, Quebec | |
| MONTREAL, Quebec, Canada, H3G 1A4 | |
| Canada, Saskatchewan | |
| SASKATOON, Saskatchewan, Canada, S7N 4H4 | |
| Germany | |
| GRENZACH-WYHLEN, Germany, 79639 | |
| VILLINGEN-SCHWENNINGEN, Germany, 78045 | |
| REGENSBURG, Germany, 93053 | |
| HALLE, Germany, 06108 | |
| WUPPERTAL, Germany, 42210 | |
| GÖTTINGEN, Germany, 37073 | |
| LEHRTE, Germany, 31275 | |
| HANNOVER, Germany, 30171 | |
| OLDENBURG, Germany, 26121 | |
| BERLIN, Germany, 13353 | |
| RAVENSBURG, Germany, 88212 | |
| MÜNCHEN, Germany, 81245 | |
| BRAUNSCHWEIG, Germany, 38100 | |
| GRENZACH-WYHLEN, Germany, 79639 | |
| KASSEL, Germany, 34125 | |
| FREIBURG, Germany, 79117 | |
| MAGDEBURG, Germany, 39130 | |
| OLDENBURG, Germany, 26133 | |
| Israel | |
| REHOVOT, Israel, 76100 | |
| HAIFA, Israel, 31096 | |
| TEL AVIV, Israel, 64239 | |
| PETAH TIKVA, Israel, 49100 | |
| PETACH TIKVA, Israel | |
| Italy | |
| MANTOVA, Italy, 46100 | |
| ROMA, Italy, 00168 | |
| VECCHIAZZANO, Italy, 47100 | |
| ROMA, Italy | |
| BOLOGNA, Italy, 40138 | |
| TORINO, Italy, 10126 | |
| LIVORNO, Italy, 57100 | |
| TORINO, Italy, 10123 | |
| TERNI, Italy, 05100 | |
| NAPOLI, Italy, 80131 | |
| ROMA, Italy, 00135 | |
| VICENZA, Italy, 36100 | |
| AVIANO, Italy, 33081 | |
| PISA, Italy, 56100 | |
| BERGAMO, Italy, 24128 | |
| CUNEO, Italy, 12100 | |
| VENEZIA, Italy, 30122 | |
| GENOVA, Italy, 16132 | |
| MILANO, Italy, 20121 | |
| NOALE (VE), Italy, 30033 | |
| MODENA, Italy, 41100 | |
| Portugal | |
| LISBOA, Portugal, 1649-035 | |
| PORTO, Portugal, 4200-072 | |
| Spain | |
| BILBAO, Spain, 48013 | |
| MADRID, Spain, 28007 | |
| PALMA DE MALLORCA, Spain, 07014 | |
| MADRID, Spain, 28040 | |
| JAEN, Spain, 23007 | |
| EL PALMAR MURCIA, Spain, 30120 | |
| ELCHE, Spain, 03202 | |
| NAVARRA, Spain, 31008 | |
| MADRID, Spain, 28002 | |
| CÓRDOBA, Spain, 14004 | |
| VALENCIA, Spain, 46010 | |
| Switzerland | |
| BASEL, Switzerland, 4070 | |
| ST GALLEN, Switzerland, 9006 | |
| BERN, Switzerland, 3010 | |
| ZÜRICH, Switzerland, 8091 | |
| BASEL, Switzerland, 4031 | |
| BELLINZONA, Switzerland, 6500 | |
| United Kingdom | |
| ABERDEEN, United Kingdom, AB25 2ZN | |
| GLASGOW, United Kingdom, G4 OSF | |
| GLASGOW, United Kingdom, G12 0YN | |
| NEWCASTLE UPON TYNE, United Kingdom, NE4 6BE | |
| BELFAST, United Kingdom, BT9 7AB | |
| CARDIFF, United Kingdom, CF14 2TL | |
| MANCHESTER, United Kingdom, M20 4BX | |
| PLYMOUTH, United Kingdom, PL6 8DH | |
| EDINBURGH, United Kingdom, EH4 2XU | |
| LEICESTER, United Kingdom, LE1 5WW | |
| NORTHWOOD, United Kingdom, HA6 2RN | |
| GUILDFORD, United Kingdom, GU2 5XX | |
| SALISBURY, United Kingdom, SP2 8BJ | |
| LUTON, United Kingdom, LU4 0DZ | |
| SOUTHAMPTON, United Kingdom, SO9 4PE | |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | M66001 |
| Study First Received: | February 2, 2001 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00009737 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |
Capecitabine Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |
