Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Capecitabine (Xeloda) and Bevacizumab 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: August 26, 2016
Last verified: August 2016
  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:


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) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS was defined as the time from randomization to progressive disease or death. Participants 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. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.

  • PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS was defined as the time from randomization to progressive disease or death. Participants 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. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.


Secondary Outcome Measures:
  • PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants 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. Participants 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 IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants 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. Participants 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 IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.

  • PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

  • Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the date of randomization to the date of death. Participants 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. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the date of randomization to the date of death. Participants 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. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

  • Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

  • BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

  • Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 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, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.

  • Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 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, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.

  • Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: Week 1 to Week 54 ] [ Designated as safety issue: No ]
    For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: Week 1 to Week 54 ] [ Designated as safety issue: No ]
    For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

  • Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

  • Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

  • Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone [ Time Frame: From baseline until disease progression/recurrence, approximately 2 years 6 months ] [ Designated as safety issue: No ]
    For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 28203
Charlotte, North Carolina, United States, 28233-3549
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, M4N 3M5
Toronto, Ontario, Canada, M5G 1X5
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M9N 1N8
Canada, Quebec
Levis, Quebec, Canada, G6V 3Z1
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H4J 1C5
Quebec City, Quebec, Canada, G1R 2J6
China
Beijing, China, 100021
Beijing, China, 100853
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, 75475
Paris, France, 75651
Paris, France, 75679
Pierre Benite, France, 69495
Rouen, France, 76031
Saint Herblain, France, 44093
Saint Herblain, France, 44805
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 City, Guatemala, 01015
Guatemala, Guatemala, 01009
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, 4
Dublin, Ireland, 8
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, 105229
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 117837
St Petersburg, Russian Federation, 197758
St Petersburg, Russian Federation, 198255
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, 28007
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Málaga, Spain, 29010
Santander, Spain, 39008
Valencia, Spain, 46009
Valencia, Spain, 46010
Valencia, Spain, 46026
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, 112
Taipei, Taiwan, 114
Thailand
Bangkok, Thailand, 10110
Bangkok, Thailand, 10700
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069095     History of Changes
Other Study ID Numbers: NO16966 
Study First Received: September 15, 2003
Results First Received: December 11, 2015
Last Updated: August 26, 2016
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
Bevacizumab
Oxaliplatin
Capecitabine
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on December 09, 2016