There are two primary purposes of the study. One is to show that the combination of capecitabine plus oxaliplatin (XELOX) with or without bevacizumab is at least as effective as the combination of fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX-4) with or without bevacizumab in terms of time to tumor progression or death in patients with metastatic colorectal cancer, who have not received previous treatment for metastatic disease. The other is to show that bevacizumab in combination with chemotherapy (XELOX or FOLFOX-4) is better than chemotherapy alone in the same patient population.

Condition	Treatment or Intervention	Phase
Metastatic Colorectal Cancer	Drug: Capecitabine	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Men or women (outpatients) at least 18 years old with good performance status
• Histologically confirmed cancer of the colon or rectum with metastatic disease
• Must have measurable tumors
• Life expectancy of at least 3 months
• Informed consent

Exclusion Criteria:

• No previous anti-cancer treatment for metastatic disease
• No previous oxaliplatin or bevacizumab. (Certain allowances included for previous radiotherapy or surgery for metastatic disease, adjuvant treatment allowed with if completed at least 6 months ago, and disease not progressed during or within 6 months.)
• Women who are pregnant or breast-feeding (including, if of childbearing potential, with a positive or no pregnancy test)
• Sexually active men and women (of childbearing potential) unwilling to practice contraception during treatment
• History of another cancer within the last five years, except basal cell skin cancer or cancer of cervix
• Ascites (abdominal fluid)
• Serious non-healing wound, ulcer or bone fracture
• Bleeding or coagulation problems
• Regular use of aspirin, NSAIDs, blood thinners
• Central nervous system disease
• Psychiatric disease
• Clinically significant cardiovascular disease within the last year
• Gastrointestinal problems such as poor absorption of nutrients or inability to digest tablets
• Certain forms of pneumonia or lung disease
• Peripheral neuropathy
• Organ transplants
• Serious uncontrolled infections
• Moderate or severe kidney disease
• Certain laboratory values
• Prior unanticipated severe reaction to fluoropyrimidine therapy
• Known DPD deficiency
• Allergy to platinum compounds or study medications
• Received another experimental drug or procedure in the past 4 weeks
• Had major surgery within 4 weeks
• Not completely recovered from major surgery
• Need for surgery during the study

Arizona
      Scottsdale,  Arizona,  85283,  United States
      Tucson,  Arizona,  85724,  United States
California
      Los Angeles,  California,  90057,  United States
      San Diego,  California,  92123,  United States
      San Diego,  California,  92120,  United States
      Sacramento,  California,  95819,  United States
      Greenbrae,  California,  94904,  United States
      Berkeley,  California,  94704,  United States
      Santa Barbara,  California,  93105,  United States
      Palo Alto,  California,  94304,  United States
      Gilroy,  California,  95020,  United States
      Vallejo,  California,  94589,  United States
      Fountain Valley,  California,  92708,  United States
      La Jolla,  California,  92093,  United States
      Orange,  California,  92868,  United States
      Fullerton,  California,  92835,  United States
Colorado
      Fort Collins,  Colorado,  80528,  United States
Connecticut
      Waterbury,  Connecticut,  06708,  United States
      Norwich,  Connecticut,  06360,  United States
Florida
      Tampa,  Florida,  33162-9497,  United States
      Tampa,  Florida,  33607,  United States
      New Port Richey,  Florida,  34652,  United States
      Gainesville,  Florida,  33610-0277,  United States
      Boca Raton,  Florida,  33486,  United States
      Jacksonville,  Florida,  32207,  United States
      Miami,  Florida,  33136,  United States
      Miami,  Florida,  33176-2197,  United States
Georgia
      Tucker,  Georgia,  30084,  United States
      Riverdale,  Georgia,  30274,  United States
      Albany,  Georgia,  31701,  United States
Illinois
      Chicago,  Illinois,  60640,  United States
      Peoria,  Illinois,  61615-7828,  United States
      Elk Grove Village,  Illinois,  60007,  United States
Kentucky
      Lexington,  Kentucky,  40536-0098,  United States
Louisiana
      New Orleans,  Louisiana,  70121,  United States
Maine
      Scarborough,  Maine,  04074,  United States
Maryland
      Rockville,  Maryland,  20850-3348,  United States
Massachusetts
      Boston,  Massachusetts,  02135,  United States
      Waltham,  Massachusetts,  02451,  United States
Michigan
      Ann Arbor,  Michigan,  48106,  United States
Minnesota
      St. Louis Park,  Minnesota,  55416,  United States
Missouri
      St. Charles,  Missouri,  63301,  United States
Nevada
      Las Vegas,  Nevada,  89106,  United States
New Jersey
      Princeton,  New Jersey,  08540,  United States
      East Orange,  New Jersey,  07019,  United States
      Hamilton,  New Jersey,  08690,  United States
      East Brunswick,  New Jersey,  08816,  United States
      New Brunswick,  New Jersey,  08901,  United States
New Mexico
      Albuquerque,  New Mexico,  87131-0001,  United States
      Farmington,  New Mexico,  87401,  United States
New York
      New York,  New York,  10021,  United States
      Syracuse,  New York,  13210,  United States
      Rochester,  New York,  14623,  United States
North Carolina
      Charlotte,  North Carolina,  28233-3549,  United States
      Charlotte,  North Carolina,  28203,  United States
      Greensboro,  North Carolina,  27401,  United States
North Dakota
      Fargo,  North Dakota,  58122,  United States
      Bismarck,  North Dakota,  58501,  United States
Pennsylvania
      Sayre,  Pennsylvania,  18840,  United States
      Upland,  Pennsylvania,  19013,  United States
Rhode Island
      Providence,  Rhode Island,  02906,  United States
South Carolina
      Columbia,  South Carolina,  29209,  United States
      Charleston,  South Carolina,  29425,  United States
Tennessee
      Memphis,  Tennessee,  38120,  United States
Texas
      Houston,  Texas,  77024,  United States
Vermont
      Burlington,  Vermont,  05401,  United States
Virginia
      Richmond,  Virginia,  23294,  United States
Washington
      Tacoma,  Washington,  98431,  United States
Wisconsin
      Madison,  Wisconsin,  53792,  United States
Australia
      Perth,  6000,  Australia
      Camperdown,  2050,  Australia
      Sydney,  2065,  Australia
      South Brisbane,  4101,  Australia
      Woodville,  5011,  Australia
      Port Macquarie,  2444,  Australia
      Melbourne,  3002,  Australia
      Melbourne,  3128,  Australia
      Footscray,  3011,  Australia
      Randwick,  2031,  Australia
      Malvern,  3144,  Australia
      Adelaide,  5005,  Australia
      Fitzroy,  3065,  Australia
      Prahran,  3181,  Australia
      Concord,  2139,  Australia
Austria
      Wien,  1090,  Austria
      Wels,  4600,  Austria
Brazil
      Belo Horizonte,  30285-000,  Brazil
      Sao Paulo,  05403-000,  Brazil
      JAÚ,  17210-080,  Brazil
      Rio de Janeiro,  20231-050,  Brazil
Canada
      Quebec,  G1R 2J6,  Canada
Canada, Alberta
      Calgary,  Alberta,  T2N 4N2,  Canada
      Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, British Columbia
      Vancouver,  British Columbia,  V5Z 4E6,  Canada
      Kelowna,  British Columbia,  V1Y 5L3,  Canada
      Surrey,  British Columbia,  V3V 1Z2,  Canada
      Victoria,  British Columbia,  V8R 6V5,  Canada
      North Vancouver,  British Columbia,  V7L 2L7,  Canada
Canada, Manitoba
      Winnipeg,  Manitoba,  R2H 2A6,  Canada
Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      London,  Ontario,  N6A 4L6,  Canada
      Toronto,  Ontario,  M4N 3M5,  Canada
      Toronto,  Ontario,  M5G 1X5,  Canada
      Toronto,  Ontario,  M5G 2M9,  Canada
      Ottawa,  Ontario,  K1H 1C4,  Canada
      Mississauga,  Ontario,  L5M 2V8,  Canada
      Weston,  Ontario,  M9N 1N8,  Canada
      Hamilton,  Ontario,  L8V 5C2,  Canada
      Oshawa,  Ontario,  L1G 2B9,  Canada
      St. Catharines,  Ontario,  L2R 5K3,  Canada
Canada, Quebec
      Montreal,  Quebec,  H1T 2M4,  Canada
      Montreal,  Quebec,  H2L 4M1,  Canada
      Montreal,  Quebec,  H4J 1C5,  Canada
      Levis,  Quebec,  G6V 3Z1,  Canada
China
      JIANGXI,  330000,  China
      Shanghai,  2000025,  China
      Shanghai,  200092,  China
      WUHAN,  430030,  China
      Beijing,  100021,  China
      Beijing,  100853,  China
      GUANGDONG,  510515,  China
      JIANGSU,  210009,  China
      SHANDONG,  250117,  China
      TIANJIN,  300060,  China
      Hong Kong,  China
      Guangzhou,  510060,  China
Czech Republic
      Praha,  140 00,  Czech Republic
      Praha,  120 00,  Czech Republic
      Brno,  656 53,  Czech Republic
      OSTRAVA PORUBA,  708 52,  Czech Republic
      HRADEC KRALOVE,  500 36,  Czech Republic
      Chomutov,  430 12,  Czech Republic
Denmark
      Odense,  5000,  Denmark
      Herlev,  2730,  Denmark
      VEJLE,  7100,  Denmark
      Koebenhavn,  2100,  Denmark
Finland
      Tampere,  36280,  Finland
      Turku,  FIN-20520,  Finland
      Helsinki,  00029,  Finland
France
      Toulouse,  31052,  France
      Paris,  75014,  France
      Paris,  75651,  France
      Paris,  75010,  France
      Lyon,  69373,  France
      Colmar,  68024,  France
      Besancon,  25030,  France
      Rouen,  76031,  France
      Strasbourg,  67091,  France
      Nice,  06189,  France
      Nice,  06202,  France
      Nimes,  30029,  France
      Grenoble,  38100,  France
      Saint-Herblain,  44093,  France
      Saint-Herblain,  44805,  France
      Brest,  29609,  France
      Brest,  29609,  France
      Chambray-les-Tours,  37044,  France
      Metz,  57070,  France
      Pierre-Benite,  69495,  France
      Bobigny,  93009,  France
      Dijon,  21079,  France
      Boulogne-Billancourt,  92104,  France
Germany
      Stuttgart,  70376,  Germany
      Trier,  54290,  Germany
      STRALSUND,  18454,  Germany
      Mannheim,  68167,  Germany
      Hannover,  30625,  Germany
      Halle,  06120,  Germany
      Bochum,  44892,  Germany
      Regensburg,  93053,  Germany
      Mainz,  55131,  Germany
      Herne,  44625,  Germany
      Leipzig,  04129,  Germany
Greece
      THESSALONIKI,  56439,  Greece
      Heraklion,  71110,  Greece
Guatemala
      GUATEMALA,  01009,  Guatemala
      Guatemala City,  01009,  Guatemala
Hungary
      Budapest,  1122,  Hungary
      Budapest,  1082,  Hungary
      Gyor,  9002,  Hungary
      Kecskemet,  6000,  Hungary
Ireland
      Dublin,  8,  Ireland
      Galway,  Ireland
      Cork,  Ireland
Israel
      Zerifin,  70300,  Israel
      Haifa,  31096,  Israel
      PETAH TIKVA,  49100,  Israel
      Tel Aviv,  64239,  Israel
      Jerusalem,  91120,  Israel
Italy
      Pavia,  27100,  Italy
      Modena,  41100,  Italy
      Parma,  43100,  Italy
      Padova,  35100,  Italy
      Genova,  16132,  Italy
      Ancona,  60020,  Italy
      Sassari,  07100,  Italy
      REGGIO EMILIA,  42100,  Italy
      ORBASSANO (TORINO),  10043,  Italy
Korea, Republic of
      Seoul,  135-170,  Korea, Republic of
Mexico
      Mexico City,  14000,  Mexico
      Tlalpan,  14000,  Mexico
New Zealand
      Christchurch,  New Zealand
Norway
      BERGEN,  5021,  Norway
      Oslo,  0407,  Norway
      TROMSOE,  9038,  Norway
Panama
      Panama,  0832-2745,  Panama
Portugal
      BEJA,  7800,  Portugal
      Lisboa,  1649-035,  Portugal
Puerto Rico
      San Juan,  00907,  Puerto Rico
Russian Federation
      Moscow,  115478,  Russian Federation
      Moscow,  117837,  Russian Federation
      Moscow,  105229,  Russian Federation
      St Petersburg,  Russian Federation
      St Petersburg,  198255,  Russian Federation
South Africa
      Pretoria,  0181,  South Africa
      SANDTON,  2199,  South Africa
      PRINSHOFF,  0002,  South Africa
      Cape Town,  7506,  South Africa
      DURBAN - NATAL,  4000,  South Africa
Spain
      Madrid,  28046,  Spain
      Madrid,  28041,  Spain
      Madrid,  28034,  Spain
      Madrid,  28007,  Spain
      Madrid,  28040,  Spain
      Valencia,  46010,  Spain
      Valencia,  46009,  Spain
      Barcelona,  08907,  Spain
      Barcelona,  08036,  Spain
      Barcelona,  08035,  Spain
      Santander,  39008,  Spain
      Malaga,  29010,  Spain
      Cordoba,  14004,  Spain
      Zaragoza,  50009,  Spain
      Leganes,  28911,  Spain
      Granada,  18014,  Spain
Sweden
      VASTERAS,  72189,  Sweden
      GAEVLE,  80187,  Sweden
      Uppsala,  75185,  Sweden
      Stockholm,  171 76,  Sweden
      KARLSTAD,  651 85,  Sweden
Switzerland
      GENEVE,  1205,  Switzerland
      Bern,  3010,  Switzerland
Taiwan, Province of China
      Taipei,  Taiwan, Province of China
      Taipei,  100,  Taiwan, Province of China
      Taipei,  112,  Taiwan, Province of China
      KUEI SHAN, TAOYUAN COUNTRY,  Taiwan, Province of China
Thailand
      Bangkok,  10700,  Thailand
      Bangkok,  10110,  Thailand
      Khon Kaen,  Thailand
Turkey
      Izmir,  35100,  Turkey
      Ankara,  06100,  Turkey
      Ankara,  06500,  Turkey
      Istanbul,  34300,  Turkey
      Istanbul,  34390,  Turkey
United Kingdom
      Nottingham,  NG5 1PB,  United Kingdom
      London,  SE1 7EH,  United Kingdom
      London,  SW3 SJJ,  United Kingdom
      Birmingham,  B18 7QH,  United Kingdom
      Glasgow,  G4 OSF,  United Kingdom
      Glasgow,  G11 6NT,  United Kingdom
      Sutton,  SM2 5PT,  United Kingdom
      Hull,  HU8 9HE,  United Kingdom
      Newcastle upon Tyne,  NE4 6BE,  United Kingdom
      Guildford,  GU2 5XX,  United Kingdom
      Edinburgh,  EH4 2XU,  United Kingdom
      Derby,  DE1 2QY,  United Kingdom
      Southampton,  SO9 4PE,  United Kingdom
      Plymouth,  PL6 8DH,  United Kingdom
      Taunton,  TA1 5DA,  United Kingdom
      Salisbury,  SP2 8BJ,  United Kingdom
      Aberdeen,  AB25 2ZN,  United Kingdom
      Northwood,  HA6 2RN,  United Kingdom
      Cardiff,  CF14 2TL,  United Kingdom
      Leeds,  LS16 5WW,  United Kingdom
      Maidstone,  ME16 9QQ,  United Kingdom

Study ID Numbers:  NO16966
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  September 15, 2003
ClinicalTrials.gov Identifier:  NCT00069095
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08