The primary purpose of the study is to show that the combination of capecitabine plus oxaliplatin (XELOX) is at least as effective as the combination of fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX4) in terms of time to tumor progression or death in patients with metastatic colorectal cancer, who have received previous treatment with CPT-11 in combination with fluorouracil/leucovorin as first line therapy.

Condition	Treatment or Intervention	Phase
Colorectal Cancer Metastases	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
• Patients with cancer that has reoccurred or progressed during or within 6 months of completion of first line therapy with the combination of CPT-11 and fluorouracil/leucovorin (5-FU/LV), or patients who stopped first line CPT-11 + 5-FU/LV within the first 8 weeks because they could not tolerate it. This previous treatment must have been completed at least 3 weeks before starting study drug, and any toxicity must have resolved.
• Certain previous radiotherapy is permitted
• Must have measurable tumors
• Life expectancy of at least 3 months
• Informed consent

Exclusion Criteria:

• No more than one previous anti-cancer treatment for metastatic disease
• No previous immunotherapy for metastatic disease
• No previous oxaliplatin
• Women who are pregnant or breast-feeding
• Women of childbearing potential with a positive or no pregnancy test
• Sexually active men and women (of childbearing potential) unwilling to practice contraception during treatment
• Previous chemotherapy, radiotherapy or immunotherapy for the current colon cancer
• Not completely recovered from surgery
• History of another cancer within the last five years except basal cell skin cancer or cancer of cervix
• History of uncontrolled seizures
• Central nervous disorders
• Clinically significant cardiac disease or myocardial infarction 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
• Major surgery within 4 weeks or not completely recovered from major surgery

Please reference Study ID Number: PDO-NO16967      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Birmingham,  Alabama,  35234,  United States; Terminated
California
      Los Angeles,  California,  90033,  United States; Terminated
      Modesto,  California,  95355,  United States; Terminated
      Bakersfield,  California,  93304,  United States; Recruiting
      Monterey,  California,  93940,  United States; Not yet recruiting
Colorado
      Colorado Springs,  Colorado,  80903,  United States; No longer recruiting
Connecticut
      Hartford,  Connecticut,  06105,  United States; Terminated
District of Columbia
      Washington,  District of Columbia,  20007-2197,  United States; Recruiting
Florida
      Bonita Springs,  Florida,  34135,  United States; Terminated
      Miami,  Florida,  33136,  United States; Terminated
      Miami,  Florida,  33133,  United States; Terminated
      Miami Beach,  Florida,  33140,  United States; Terminated
Illinois
      Chicago,  Illinois,  60611,  United States; Terminated
Indiana
      Terre Haute,  Indiana,  47802,  United States; Recruiting
Iowa
      Des Moines,  Iowa,  50309,  United States; Terminated
Maryland
      Baltimore,  Maryland,  21201,  United States; Terminated
Massachusetts
      Waltham,  Massachusetts,  02451,  United States; Completed
      Franklin,  Massachusetts,  02038,  United States; Completed
Missouri
      St. Louis,  Missouri,  63136,  United States; Recruiting
Montana
      Billings,  Montana,  59101,  United States; Completed
      Great Falls,  Montana,  59405,  United States; Terminated
Nebraska
      Omaha,  Nebraska,  68114-4108,  United States; Completed
New Jersey
      Princeton,  New Jersey,  08540,  United States; Completed
      Summit,  New Jersey,  07901,  United States; Terminated
New Mexico
      Albuquerque,  New Mexico,  87109,  United States; Not yet recruiting
New York
      New York,  New York,  10003,  United States; Terminated
      Rockville Centre,  New York,  11570,  United States; Terminated
      Williamsville,  New York,  14221,  United States; Terminated
      Nyack,  New York,  10960,  United States; No longer recruiting
North Carolina
      Cary,  North Carolina,  27511,  United States; Completed
      Hickory,  North Carolina,  28602,  United States; Terminated
Pennsylvania
      Kingston,  Pennsylvania,  18704,  United States; Terminated
      Bethlehem,  Pennsylvania,  18015,  United States; Terminated
Tennessee
      Nashville,  Tennessee,  37232-2103,  United States; Recruiting
      Nashville,  Tennessee,  37232,  United States; Terminated
      Memphis,  Tennessee,  38120,  United States; Terminated
Texas
      Dallas,  Texas,  75204,  United States; Recruiting
Utah
      Salt Lake City,  Utah,  84112,  United States; Terminated
Vermont
      White River Junction,  Vermont,  05001,  United States; Terminated
Washington
      Burien,  Washington,  98166,  United States; Terminated
      Yakima,  Washington,  98902,  United States; Terminated
      Puyallup,  Washington,  98372,  United States; Terminated
Wisconsin
      Wausau,  Wisconsin,  54401,  United States; Recruiting
Belgium
      BRUXELLES,  1070,  Belgium; Recruiting
      BRUXELLES,  1000,  Belgium; Recruiting
      Gent,  9000,  Belgium; Recruiting
      Kortrijk,  8500,  Belgium; Recruiting
      Charleroi,  6000,  Belgium; Terminated
      MONT-GODINNE/YVOIR,  5530,  Belgium; Recruiting
Canada
      Quebec,  G1R 2J6,  Canada; Recruiting
Canada, Alberta
      Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
Canada, British Columbia
      Vancouver,  British Columbia,  V5Z 4E6,  Canada; Terminated
Canada, Newfoundland and Labrador
      St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 1V7,  Canada; Recruiting
Canada, Ontario
      London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting
      Toronto,  Ontario,  M4C 3E7,  Canada; Terminated
      Ottawa,  Ontario,  K1H 1C4,  Canada; Recruiting
      Weston,  Ontario,  M9N 1N8,  Canada; Recruiting
      Oshawa,  Ontario,  L1G 2B9,  Canada; Recruiting
      St. Catharines,  Ontario,  L2R 5K3,  Canada; Recruiting
      Thunder Bay,  Ontario,  P7A 7T1,  Canada; Recruiting
Canada, Quebec
      Montreal,  Quebec,  H1T 2M4,  Canada; Recruiting
      Montreal,  Quebec,  H4J 1C5,  Canada; Recruiting
      Montreal,  Quebec,  H2W 1S6,  Canada; Recruiting
      Levis,  Quebec,  G6V 3Z1,  Canada; Recruiting
      Laval,  Quebec,  H7M 3L9,  Canada; Recruiting
Canada, Saskatchewan
      Regina,  Saskatchewan,  S4T 7T1,  Canada; Recruiting
Croatia
      Zagreb,  10000,  Croatia; Recruiting
      Split,  21000,  Croatia; Recruiting
Finland
      Tampere,  36280,  Finland; Recruiting
      Turku,  FIN-20520,  Finland; Recruiting
France
      Paris,  75908,  France; Recruiting
      Lyon,  69008,  France; Completed
      Rouen,  76031,  France; Recruiting
      Limoges,  87042,  France; Recruiting
      Nimes,  30029,  France; Recruiting
      Bordeaux,  France; Recruiting
      Bordeaux,  33076,  France; Recruiting
      Chambray-les-Tours,  37044,  France; Recruiting
      Avignon,  84082,  France; Recruiting
      Pessac,  33604,  France; Recruiting
Germany
      Tuebingen,  72076,  Germany; Recruiting
      Trier,  54290,  Germany; Not yet recruiting
      Herne,  44625,  Germany; Terminated
      LEMGO,  32657,  Germany; Completed
      LEMGO,  32657,  Germany; Terminated
Greece
      THESSALONIKI,  56439,  Greece; Recruiting
      Heraklion,  71110,  Greece; Recruiting
Israel
      Haifa,  35152,  Israel; Terminated
      PETAH TIKVA,  49100,  Israel; Recruiting
      Tel Aviv,  64239,  Israel; Recruiting
      Jerusalem,  91031,  Israel; Recruiting
      Rehovot,  76100,  Israel; Recruiting
      RAMAT-GAN,  52621,  Israel; Recruiting
      Kfar Saba,  44281,  Israel; Recruiting
      Beer-Sheva,  Israel; Recruiting
Italy
      Bergamo,  24128,  Italy; Recruiting
      Livorno,  57100,  Italy; Recruiting
      Udine,  33100,  Italy; Recruiting
      Cattolica,  47841,  Italy; Recruiting
      Rimini,  47037,  Italy; Recruiting
      Aviano,  33081,  Italy; Not yet recruiting
Korea, Republic of
      Seoul,  110-744,  Korea, Republic of; Recruiting
      Seoul,  138-736,  Korea, Republic of; Recruiting
      Seoul,  133-792,  Korea, Republic of; Recruiting
      Seoul,  120-752,  Korea, Republic of; Recruiting
      Seoul,  137-040,  Korea, Republic of; Recruiting
      BUCHUN,  420-021,  Korea, Republic of; Recruiting
Poland
      Warszawa,  02-781,  Poland; Recruiting
      Warszawa,  04-394,  Poland; Recruiting
      Krakow,  31-501,  Poland; Recruiting
      Bialystok,  15-027,  Poland; Recruiting
Puerto Rico
      San Juan,  00921-3201,  Puerto Rico; Recruiting
Slovakia
      Kosice,  041 90,  Slovakia; Terminated
      BRATISLAVA,  831 01,  Slovakia; Not yet recruiting
Slovenia
      LJUBLJANA,  1000,  Slovenia; Recruiting
South Africa
      Durban,  4001,  South Africa; Recruiting
      Pretoria,  South Africa; Recruiting
      Cape Town,  7500,  South Africa; Recruiting
      PIETERMARITZBURG,  3201,  South Africa; Recruiting
      Port Elizabeth,  6001,  South Africa; Recruiting
Spain
      Madrid,  28041,  Spain; Recruiting
      Madrid,  28034,  Spain; Recruiting
      Madrid,  28035,  Spain; Recruiting
      Barcelona,  08907,  Spain; Recruiting
      Barcelona,  08036,  Spain; Recruiting
      Palma de Mallorca,  07014,  Spain; Recruiting
      Malaga,  29010,  Spain; Terminated
      Zaragoza,  50009,  Spain; Terminated
      Leganes,  28911,  Spain; Recruiting
      Granada,  18014,  Spain; Recruiting
Taiwan, Province of China
      Taipei,  104,  Taiwan, Province of China; Recruiting
      Tainan,  Taiwan, Province of China; Recruiting
      Taoyuan,  Taiwan, Province of China; Recruiting
      TAINAN COUNTY,  710,  Taiwan, Province of China; Not yet recruiting
Turkey
      Izmir,  35340,  Turkey; Not yet recruiting
      Ankara,  Turkey; Not yet recruiting
      Ankara,  06018,  Turkey; Not yet recruiting
      ANTALYA,  07070,  Turkey; Not yet recruiting
      KAYSERI,  38039,  Turkey; Not yet recruiting
United Kingdom
      London,  SW3 SJJ,  United Kingdom; Terminated
      London,  W12 0NN,  United Kingdom; Terminated
      London,  W1P 8B2,  United Kingdom; Terminated
      Manchester,  M20 4BX,  United Kingdom; Recruiting
      Sutton,  SM2 5PT,  United Kingdom; Recruiting
      Denbigh,  LL18 5UJ,  United Kingdom; Recruiting
      MERSEYSIDE,  CH63 45Y,  United Kingdom; Recruiting
      Preston,  PR2 9HT,  United Kingdom; Recruiting
Yugoslavia
      BELGRADE,  11000,  Yugoslavia; Recruiting

Study ID Numbers:  NO16967
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  September 15, 2003
ClinicalTrials.gov Identifier:  NCT00069108
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08