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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00069095 |
Purpose
This 4 arm study will assess the efficacy and safety of oral Xeloda, or intravenous (iv) fluorouracil/leucovorin, in combination with iv Eloxatin (oxaliplatin) with or without iv Avastin as a first-line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin), in 3 week cycles, 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles), 3) XELOX + Avastin (7.5 mg iv on day 1)in 3 week cycles or 4)FOLFOX-4 + Avastin (5mg iv on day 1)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: capecitabine [Xeloda] Drug: Oxaliplatin Drug: Leucovorin Drug: 5 FU Drug: Avastin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-label Study Comparing the Effect of First-line Treatment With Intermittent Xeloda Versus Fluorouracil/Leucovorin, Both in Combination With Eloxatin With or Without Avastin, on Tumor Progression in Patients With Metastatic Colorectal Cancer |
| Enrollment: | 2035 |
| Study Completion Date: | November 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle.
|
| 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.
|
| 3: Active Comparator |
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle.
Drug: Oxaliplatin
As prescribed in 3 week cycles
Drug: Avastin
7.5mg iv on day 1 in each 3 week cycle
|
| 4: Active Comparator |
Drug: Leucovorin
As prescribed, in 2 week cycles
Drug: 5 FU
As prescribed, in 2 week cycles.
Drug: Avastin
5mg iv on day 1 of each 2 week cycle
|
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, California | |
| Berkeley, California, United States, 94704 | |
| Los Angeles, California, United States, 90057 | |
| San Diego, California, United States, 92123 | |
| Greenbrae, California, United States, 94904 | |
| Fountain Valley, California, United States, 92708 | |
| Fullerton, California, United States, 92835 | |
| Gilroy, California, United States, 95020 | |
| Palo Alto, California, United States, 94304 | |
| Orange, California, United States, 92868 | |
| United States, Connecticut | |
| Waterbury, Connecticut, United States, 06708 | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Florida | |
| Gainesville, Florida, United States, 33610-0277 | |
| Tampa, Florida, United States, 33612 | |
| New Port Richey, Florida, United States, 34652 | |
| Boca Raton, Florida, United States, 33486 | |
| Tampa, Florida, United States, 33607 | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30341 | |
| United States, Illinois | |
| Peoria, Illinois, United States, 61615-7828 | |
| Chicago, Illinois, United States, 60640 | |
| Elk Grove Village, Illinois, United States, 60007 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40536-0098 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maine | |
| Scarborough, Maine, United States, 04074 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02135 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| St Louis Park, Minnesota, United States, 55416 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| East Orange, New Jersey, United States, 07019 | |
| Hamilton, New Jersey, United States, 08690 | |
| United States, New Mexico | |
| Farmington, New Mexico, United States, 87401 | |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| United States, New York | |
| Syracuse, New York, United States, 13210 | |
| New York, New York, United States, 10021 | |
| Rochester, New York, United States, 14623 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, North Dakota | |
| Fargo, North Dakota, United States, 58122 | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Pennsylvania | |
| Sayre, Pennsylvania, United States, 18840 | |
| Upland, Pennsylvania, United States, 19013 | |
| United States, Rhode Island | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Columbia, South Carolina, United States, 29209 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Houston, Texas, United States, 77024 | |
| United States, Vermont | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23294 | |
| Australia | |
| Sydney, Australia, 2050 | |
| Port Macquarie, Australia, 2444 | |
| Perth, Australia, 6000 | |
| Melbourne, Australia, 3181 | |
| Adelaide, Australia, 5011 | |
| Footscray, Australia, 3011 | |
| Melbourne, Australia, 3002 | |
| Brisbane, Australia, 4101 | |
| Sydney, Australia, 2031 | |
| Melbourne, Australia, 3128 | |
| Kurralta Park, Australia, 5037 | |
| St. Leonards, Australia, 2065 | |
| Fitzroy, Australia, 3065 | |
| Malvern, Australia, 3144 | |
| Sydney, Australia, 2139 | |
| Austria | |
| Wien, Austria, 1090 | |
| Wels, Austria, 4600 | |
| Brazil | |
| Jaú, Brazil, 17210-080 | |
| Sao Paulo, Brazil, 05403-000 | |
| Rio de Janeiro, Brazil, 20231-050 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| North Vancouver, British Columbia, Canada, V7L 2L7 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Toronto, Ontario, Canada, M9N 1N8 | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| London, Ontario, Canada, N6A 4L6 | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| St. Catharines, Ontario, Canada, L2R 7C6 | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Canada, Quebec | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| China | |
| Beijing, China, 100021 | |
| Shanghai, China, 200025 | |
| Wuhan, China, 430030 | |
| Shanghai, China, 200092 | |
| Guangzhou, China, 510060 | |
| Guangdong, China, 510515 | |
| Jiangsu, China, 210009 | |
| Shandong, China, 250117 | |
| Beijing, China, 100853 | |
| Tianjin, China, 300060 | |
| Jiangxi, China, 330000 | |
| Czech Republic | |
| Hradec Kralove, Czech Republic, 500 36 | |
| Chomutov, Czech Republic, 430 12 | |
| Brno, Czech Republic, 656 53 | |
| Ostrava, Czech Republic, 708 52 | |
| Denmark | |
| Odense, Denmark, 5000 | |
| København, Denmark, 2100 | |
| Herlev, Denmark, 2730 | |
| Finland | |
| Tampere, Finland, 33520 | |
| Helsinki, Finland, 00029 | |
| Turku, Finland, 20520 | |
| France | |
| Nice, France, 06202 | |
| Brest, France, 29609 | |
| Saint Herblain, France, 44093 | |
| Colmar, France, 68024 | |
| Metz, France, 57070 | |
| Chambray-lès-tours, France, 37044 | |
| Nimes, France, 30029 | |
| Besancon, France, 25030 | |
| Nice, France, 06189 | |
| Saint Herblain, France, 44805 | |
| Toulouse, France, 31052 | |
| Lyon, France, 69373 | |
| Boulogne-billancourt, France, 92104 | |
| Rouen, France, 76031 | |
| Bobigny, France, 93009 | |
| Grenoble, France, 38100 | |
| Paris, France, 75651 | |
| Paris, France, 75014 | |
| Pierre Benite, France, 69495 | |
| Dijon, France, 21000 | |
| Paris, France, 75475 | |
| Germany | |
| Trier, Germany, 54290 | |
| Stralsund, Germany, 18435 | |
| Regensburg, Germany, 93053 | |
| Halle, Germany, 06120 | |
| Bochum, Germany, 44892 | |
| Mannheim, Germany, 68167 | |
| Hannover, Germany, 30625 | |
| Mainz, Germany, 55101 | |
| Herne, Germany, 44625 | |
| Leipzig, Germany, 04129 | |
| Guatemala | |
| Guatemala City, Guatemala, 01015 | |
| Guatemala City, Guatemala, 01009 | |
| Hong Kong | |
| Hong Kong, Hong Kong | |
| Hungary | |
| Gyor, Hungary, 9023 | |
| Budapest, Hungary, 1122 | |
| Budapest, Hungary, 1082 | |
| Kecskemet, Hungary, 6000 | |
| Ireland | |
| Cork, Ireland | |
| Dublin, Ireland, 4 | |
| Galway, Ireland | |
| Dublin, Ireland, 8 | |
| Israel | |
| Tel Aviv, Israel, 64239 | |
| Haifa, Israel, 31096 | |
| Petach Tikva, Israel, 49100 | |
| Jerusalem, Israel, 91120 | |
| Zerifin, Israel, 70300 | |
| Italy | |
| Genova, Italy, 16132 | |
| Ancona, Italy, 60121 | |
| Sassari, Italy, 07100 | |
| Parma, Italy, 43100 | |
| Genova, Italy, 16132 | |
| Reggio Emilia, Italy, 42100 | |
| Modena, Italy, 41100 | |
| Padova, Italy, 35100 | |
| Pavia, Italy, 27100 | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 135-170 | |
| Mexico | |
| Mexico City, Mexico, 14000 | |
| New Zealand | |
| Christchurch, New Zealand | |
| Norway | |
| Bergen, Norway, 5021 | |
| Oslo, Norway, 0407 | |
| Tromsø, Norway, 9038 | |
| Panama | |
| Panama City, Panama | |
| Portugal | |
| Lisboa, Portugal, 1649-035 | |
| Beja, Portugal, 7801-849 | |
| Puerto Rico | |
| San Juan, Puerto Rico, 00907 | |
| Russian Federation | |
| Moscow, Russian Federation, 115478 | |
| Moscow, Russian Federation, 117837 | |
| St Petersburg, Russian Federation, 198255 | |
| St Petersburg, Russian Federation, 197758 | |
| Moscow, Russian Federation, 105229 | |
| South Africa | |
| Sandton, South Africa, 2196 | |
| Pretoria, South Africa, 0001 | |
| Cape Town, South Africa, 7506 | |
| Spain | |
| Madrid, Spain, 28007 | |
| Barcelona, Spain, 08035 | |
| Santander, Spain, 39008 | |
| Valencia, Spain, 46010 | |
| Madrid, Spain, 28040 | |
| Barcelona, Spain, 08907 | |
| Valencia, Spain, 46009 | |
| Córdoba, Spain, 14004 | |
| Madrid, Spain, 28041 | |
| Barcelona, Spain, 08036 | |
| Madrid, Spain, 28046 | |
| Madrid, Spain, 28034 | |
| Zaragoza, Spain, 50009 | |
| Leganes, Spain, 28911 | |
| Granada, Spain, 18014 | |
| Málaga, Spain, 29010 | |
| Sweden | |
| Västerås, Sweden, 72189 | |
| Uppsala, Sweden, 75185 | |
| Stockholm, Sweden, 17176 | |
| Gaevle, Sweden, 80187 | |
| Karlstad, Sweden, 65185 | |
| Switzerland | |
| Bern, Switzerland, 3010 | |
| Geneve, Switzerland, 1205 | |
| Taiwan | |
| Taipei, Taiwan, 100 | |
| Taipei, Taiwan, 114 | |
| Taipei, Taiwan, 112 | |
| Kueishan, Taiwan, 333 | |
| Thailand | |
| Bangkok, Thailand, 10700 | |
| Khon Kaen, Thailand, 40002 | |
| Bangkok, Thailand, 10110 | |
| Turkey | |
| Istanbul, Turkey, 34300 | |
| Izmir, Turkey, 35100 | |
| United Kingdom | |
| Guildford, United Kingdom, GU2 5XX | |
| Sutton, United Kingdom, SM2 5PT | |
| Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
| Birmingham, United Kingdom, B18 7QH | |
| Glasgow, United Kingdom, G12 0YN | |
| Aberdeen, United Kingdom, AB25 2ZN | |
| Northwood, United Kingdom, HA6 2RN | |
| Taunton, United Kingdom, TA1 5DA | |
| Southampton, United Kingdom, SO9 4PE | |
| Salisbury, United Kingdom, SP2 8BJ | |
| Cardiff, United Kingdom, CF14 2TL | |
| Derby, United Kingdom, DE1 2QY | |
| London, United Kingdom, SW3 6JJ | |
| Hull, United Kingdom, HU8 9HE | |
| Maidstone, United Kingdom, ME16 9QQ | |
| Nottingham, United Kingdom, NG5 1PB | |
| Plymouth, United Kingdom, PL6 8DH | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche ( Disclosures Group ) |
| Study ID Numbers: | NO16966 |
| Study First Received: | September 15, 2003 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00069095 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 Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Micronutrients Capecitabine Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
