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A Study of Capecitabine (Xeloda) as a First-line Therapy in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00069095
First received: September 15, 2003
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m^2 orally [po] twice a day [bid] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil [5-FU] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).


Condition Intervention Phase
Colorectal Cancer
 Drug: Oxaliplatin 130 mg/m^2
Drug: Capecitabine 1000 mg/m^2
Drug: Bevacizumab 7.5 mg/kg
Drug: Placebo for bevacizumab 7.5 mg/kg
Drug: Oxaliplatin 85 mg/m^2
Drug: Leucovorin 200 mg/m^2
Drug: Fluorouracil 400 mg/m^2
Drug: Bevacizumab 5 mg/kg
Drug: Placebo for bevacizumab 5 mg/kg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (PFS) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    PFS was defined as the time from randomization to disease progression (PD) or death. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter(SLD). All other lesions were identified as non-TLs and recorded at baseline. PD for TLs was defined as ≥ 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Patients with neither PD nor death were censored at the date of the last tumor assessment that confirmed no PD. Patients who underwent surgical resection with curative intent without prior progression were censored at the date of surgery.


Secondary Outcome Measures:
  • Progression-free survival (PFS) as assessed by the Independent Review Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Patients with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Patients who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the Independent Review Committee.

  • Best overall response (BOR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    BOR in an individual patient was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments by the investigator made up to 28 days after the last study treatment in the primary study treatment phase not later than the date of the first curative surgery were included in the analysis. Responders were defined as the percentage of patients with a complete response (CR) or partial response (PR). For target lesions (TL), a CR was defined as the disappearance of all TLs and a PR was defined as ≥ 30% decrease in the SLD of target lesions, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs.

  • Best overall response (BOR) as assessed by the Independent Review Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    Only tumor assessments by the Independent Review Committee made up to 28 days after the last study treatment in the primary study treatment phase not later than the date of the first curative surgery were included in the analysis. Responders were defined as the percentage of patients with a complete response (CR) or partial response (PR).

  • Overall survival [ Time Frame: Baseline to the 30 May 2008 data cut-off (up to 4 years 10 months) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the date of randomization to the date of death. Patients who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive.

  • Time to response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    For patients whose best overall response was CR or PR, time to response was defined as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met. Results are reported as the percentage of patients achieving a response in 8 time categories from Week 1 to Week 54.

  • Duration of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    Duration of response was defined as the time that measurement criteria are first met for complete response (CR) or partial response (PR) (whichever status is recorded first) until the first date that progressive disease (PD) or death is documented. PD for target lesions was defined as ≥ 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. PD for non-target lesions was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-targets.

  • Duration of complete response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    Duration of complete response was defined as the time measurement criteria are first met for a complete response until the date that progressive disease (or death) is documented.

  • Time to treatment failure as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the 10 Feb 2005 data cut-off (up to 1 year 7 months) ] [ Designated as safety issue: No ]
    Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, patient refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurs first.


Enrollment: 2035
Study Start Date: July 2003
Study Completion Date: April 2009
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XELOX (oxaliplatin+capecitabine)
Patients in the 2-arm part of the study received oxaliplatin 130 mg/m^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m^2 orally twice a day for the first 2 weeks of every 3 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
 Drug: Oxaliplatin 130 mg/m^2
Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
Other Name: Eloxatin
Drug: Capecitabine 1000 mg/m^2
Capecitabine was taken within 30 min after the end of breakfast and dinner.
Other Name: Xeloda
Drug: Placebo for bevacizumab 7.5 mg/kg
Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
Experimental: XELOX (oxaliplatin+capecitabine) + bevacizumab
Patients in the 4-arm part of the study received oxaliplatin 130 mg/m^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m^2 orally twice a day for the first 2 weeks of every 3 week cycle + bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
 Drug: Oxaliplatin 130 mg/m^2
Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
Other Name: Eloxatin
Drug: Capecitabine 1000 mg/m^2
Capecitabine was taken within 30 min after the end of breakfast and dinner.
Other Name: Xeloda
Drug: Bevacizumab 7.5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.
Other Name: Avastin
Active Comparator: FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)
Patients in the 2-arm part of the study received oxaliplatin 85 mg/m^2 intravenously (iv) + leucovorin 200 mg/m^2 iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle.
 Drug: Oxaliplatin 85 mg/m^2
Oxaliplatin 85 mg/m^2 was administered simultaneously with leucovorin in a 2 h infusion.
Other Name: Eloxatin
Drug: Leucovorin 200 mg/m^2
Leucovorin was administered simultaneously with oxaliplatin 85 mg/m^2 in a 2 h infusion.
Drug: Fluorouracil 400 mg/m^2
Other Name: Efudex
Drug: Placebo for bevacizumab 5 mg/kg
Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
Active Comparator: FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab
Patients in the 4-arm part of the study received oxaliplatin 85 mg/m^2 intravenously (iv) + leucovorin 200 mg/m^2 iv + bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle.
 Drug: Oxaliplatin 85 mg/m^2
Oxaliplatin 85 mg/m^2 was administered simultaneously with leucovorin in a 2 h infusion.
Other Name: Eloxatin
Drug: Leucovorin 200 mg/m^2
Leucovorin was administered simultaneously with oxaliplatin 85 mg/m^2 in a 2 h infusion.
Drug: Fluorouracil 400 mg/m^2
Other Name: Efudex
Drug: Bevacizumab 5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.
Other Name: Avastin

Detailed Description:

This study was conducted in 2 parts: An initial 2-arm part in which patients were randomized to 1 of 2 different treatment groups (XELOX or FOLFOX-4), and a subsequent 2 x 2 factorial part, added to the study through a protocol amendment, in which additional patients were randomized into one of 4 different treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, or FOLFOX-4 + bevacizumab). Due to the comparison of the oral agent capecitabine with bolus and infused fluorouracil, the study was not blinded with respect to these 2 treatments. The study was double-blind with regard to the administration of bevacizumab, ie, there was a placebo control for bevacizumab in the second part of the study.

The study consisted of 3 phases, a Primary Study Treatment Phase, a Post-Study Treatment Phase, and a Follow-Up Phase.

Primary Study Treatment Phase

Patients were to receive up to 16 cycles (2-arm part of the study) or 24 cycles (4-arm part of the study) of treatment during the Primary Study Treatment Phase (48 weeks).

Post-Study Treatment Phase

Patients who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Patients who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the patient withdrew consent.

Follow-up Phase

Patients who terminated study treatment during the primary or post-study treatment phase were followed until disease progression or death.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ≥ 18 years of age.
  • Metastatic colorectal cancer.
  • ≥ 1 target lesion.

Exclusion Criteria:

  • Previous treatment with oxaliplatin or bevacizumab.
  • Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
  • Progressive disease during or within 6 months of completion of previous adjuvant therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069095

  Hide Study Locations
Locations
United States, California
Berkeley, California, United States, 94704
Fountain Valley, California, United States, 92708
Fullerton, California, United States, 92835
Gilroy, California, United States, 95020
Greenbrae, California, United States, 94904
Los Angeles, California, United States, 90057
Orange, California, United States, 92868
Palo Alto, California, United States, 94304
San Diego, California, United States, 92123
United States, Connecticut
Norwich, Connecticut, United States, 06360
Waterbury, Connecticut, United States, 06708
United States, Florida
Boca Raton, Florida, United States, 33486
Gainesville, Florida, United States, 33610-0277
Jacksonville, Florida, United States, 32207
New Port Richey, Florida, United States, 34652
Tampa, Florida, United States, 33607
Tampa, Florida, United States, 33647
United States, Georgia
Atlanta, Georgia, United States, 30341
United States, Illinois
Chicago, Illinois, United States, 60640
Elk Grove Village, Illinois, United States, 60007
Peoria, Illinois, United States, 61615-7828
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
East Orange, New Jersey, United States, 07019
Hamilton, New Jersey, United States, 08690
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
Albuquerque, New Mexico, United States, 87131-0001
Farmington, New Mexico, United States, 87401
United States, New York
New York, New York, United States, 10065
Rochester, New York, United States, 14623
Syracuse, New York, United States, 13210
United States, North Carolina
Charlotte, North Carolina, United States, 28233-3549
Charlotte, North Carolina, United States, 28203
United States, North Dakota
Bismarck, North Dakota, United States, 58501
Fargo, North Dakota, United States, 58122
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
Adelaide, Australia, 5011
Box Hill, Australia, 3128
Brisbane, Australia, 4101
Camperdown, Australia, 2050
Fitzroy, Australia, 3065
Footscray, Australia, 3011
Kurralta Park, Australia, 5037
Malvern, Australia, 3144
Melbourne, Australia, 3002
Melbourne, Australia, 3181
Perth, Australia, 6000
Port Macquarie, Australia, 2444
St. Leonards, Australia, 2065
Sydney, Australia, 2031
Sydney, Australia, 2139
Austria
Wels, Austria, 4600
Wien, Austria, 1090
Brazil
JAÚ, Brazil, 17210-080
Rio de Janeiro, Brazil, 20231-050
Sao Paulo, Brazil, 05403-000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
North Vancouver, British Columbia, Canada, V7L 2L7
Surrey, British Columbia, Canada, V3V 1Z2
Vancouver, British Columbia, Canada, V5Z 1H5
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
London, Ontario, Canada, N6A 4L6
Mississauga, Ontario, Canada, L5M 2N1
Oshawa, Ontario, Canada, L1G 2B9
Ottawa, Ontario, Canada, K1H 8L6
St. Catharines, Ontario, Canada, L2R 7C6
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M5G 1X5
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M9N 1N8
Canada, Quebec
Levis, Quebec, Canada, G6V 3Z1
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H4J 1C5
Quebec City, Quebec, Canada, G1R 2J6
China
Beijing, China, 100853
Beijing, China, 100021
Guangdong, China, 510515
Guangzhou, China, 510060
Jiangsu, China, 210009
Jiangxi, China, 330000
Shandong, China, 250117
Shanghai, China, 200025
Shanghai, China, 200092
Tianjin, China, 300060
Wuhan, China, 430030
Czech Republic
Brno, Czech Republic, 656 53
Chomutov, Czech Republic, 430 12
Hradec Kralove, Czech Republic, 500 36
Ostrava, Czech Republic, 708 52
Denmark
Herlev, Denmark, 2730
København, Denmark, 2100
Odense, Denmark, 5000
Finland
Helsinki, Finland, 00029
Tampere, Finland, 33520
Turku, Finland, 20520
France
Besancon, France, 25030
Bobigny, France, 93009
Boulogne-billancourt, France, 92104
Brest, France, 29609
Chambray Les Tours, France, 37171
Colmar, France, 68024
Dijon, France, 21079
Grenoble, France, 38100
Lyon, France, 69373
Metz, France, 57072
Nice, France, 06189
Nice, France, 06202
Nimes, France, 30029
Paris, France, 75651
Paris, France, 75475
Paris, France, 75679
Pierre Benite, France, 69495
Rouen, France, 76031
Saint Herblain, France, 44805
Saint Herblain, France, 44093
Toulouse, France, 31052
Germany
Bochum, Germany, 44892
Halle, Germany, 06120
Hannover, Germany, 30625
Herne, Germany, 44625
Leipzig, Germany, 04129
Mainz, Germany, 55131
Mannheim, Germany, 68167
Regensburg, Germany, 93053
Stralsund, Germany, 18435
Trier, Germany, 54290
Guatemala
Guatemala, Guatemala, 01009
Guatemala City, Guatemala, 01015
Hong Kong
Hong Kong, Hong Kong
Hungary
Budapest, Hungary, 1082
Budapest, Hungary, H-1122
Gyor, Hungary, 9002
Kecskemet, Hungary, 6000
Ireland
Cork, Ireland
Dublin, Ireland, 8
Dublin, Ireland, 4
Galway, Ireland
Israel
Haifa, Israel, 31096
Jerusalem, Israel, 91120
Petach Tikva, Israel, 49100
Tel Aviv, Israel, 64239
Zerifin, Israel, 70300
Italy
Ancona, Italy, 60121
Genova, Italy, 16132
Modena, Italy, 41100
Padova, Italy, 35100
Parma, Italy, 43100
Pavia, Italy, 27100
Reggio Emilia, Italy, 42100
Sassari, Italy, 07100
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
Beja, Portugal, 7801-849
Lisboa, Portugal, 1649-035
Puerto Rico
San Juan, Puerto Rico, 00907
Russian Federation
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 105229
St Petersburg, Russian Federation, 198255
St Petersburg, Russian Federation, 197758
South Africa
Cape Town, South Africa, 7506
Pretoria, South Africa, 0001
Sandton, South Africa, 2199
Spain
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Córdoba, Spain, 14004
Granada, Spain, 18014
Leganes, Spain, 28911
Madrid, Spain, 28046
Madrid, Spain, 28040
Madrid, Spain, 28007
Madrid, Spain, 28041
Madrid, Spain, 28034
Málaga, Spain, 29010
Santander, Spain, 39008
Valencia, Spain, 46009
Valencia, Spain, 46026
Valencia, Spain, 46010
Zaragoza, Spain, 50009
Sweden
Gaevle, Sweden, 80187
Karlstad, Sweden, 65185
Stockholm, Sweden, 17176
Uppsala, Sweden, 751 85
Västerås, Sweden, 72189
Switzerland
Bern, Switzerland, 3010
Geneve, Switzerland, 1205
Taiwan
Kueishan, Taiwan, 333
Taipei, Taiwan, 100
Taipei, Taiwan, 114
Taipei, Taiwan, 112
Thailand
Bangkok, Thailand, 10700
Bangkok, Thailand, 10110
Khon Kaen, Thailand, 40002
Turkey
Istanbul, Turkey, 34300
Izmir, Turkey, 35100
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Birmingham, United Kingdom, B18 7QH
Cardiff, United Kingdom, CF14 2TL
Derby, United Kingdom, DE1 2QY
Glasgow, United Kingdom, G12 0YN
Guildford, United Kingdom, GU2 7XX
Hull, United Kingdom, HU8 9HE
London, United Kingdom, SW3 6JJ
Maidstone, United Kingdom, ME16 9QQ
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Northwood, United Kingdom, HA6 2RN
Nottingham, United Kingdom, NG5 1PB
Plymouth, United Kingdom, PL6 8DH
Salisbury, United Kingdom, SP2 8BJ
Southampton, United Kingdom, SO9 4PE
Sutton, United Kingdom, SM2 5PT
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069095     History of Changes
Other Study ID Numbers: NO16966
Study First Received: September 15, 2003
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Capecitabine
Oxaliplatin
Bevacizumab
 Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013