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Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon

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ClinicalTrials.gov Identifier: NCT00314353
Recruitment Status : Terminated (The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.)
First Posted : April 13, 2006
Results First Posted : December 2, 2008
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Genentech, Inc.
Hoffmann-La Roche
International Drug Development Institute
Information provided by (Responsible Party):
NSABP Foundation Inc

Tracking Information
First Submitted Date  ICMJE April 11, 2006
First Posted Date  ICMJE April 13, 2006
Results First Submitted Date  ICMJE November 7, 2008
Results First Posted Date  ICMJE December 2, 2008
Last Update Posted Date May 8, 2018
Study Start Date  ICMJE March 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
One-year Progression-free Survival (PFS) [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
Proportion of patients who are alive and free of progression one year after starting therapy
Change History Complete list of historical versions of study NCT00314353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
  • Objective Response Rate [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]
  • Toxicity - Adverse Events [ Time Frame: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab ]
  • Overall Survival [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]
  • Duration of Response [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
An evaluation of response rate (reduction in tumor), toxicity, overall survival, progression-free survival, and duration of response.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
Official Title  ICMJE Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
Brief Summary Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
Detailed Description Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Drug: Bevacizumab

    7.5 mg/kg IV Day 1 every 21 days for eight cycles*

    *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.

    Other Name: Avastin
  • Drug: Oxaliplatin
    130 mg/m2 IV Day 1 every 21 days for eight cycles
    Other Name: Eloxatin
  • Drug: Capecitabine

    850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*#

    *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.

    #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID

    Other Name: Xeloda
  • Drug: Irinotecan
    200 mg/m2 IV Day 1 every 21 days for eight cycles
    Other Name: Camptosar
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: Bevacizumab
    • Drug: Oxaliplatin
    • Drug: Capecitabine
  • Experimental: 2
    Interventions:
    • Drug: Bevacizumab
    • Drug: Capecitabine
    • Drug: Irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
7
Original Enrollment  ICMJE
 (submitted: April 11, 2006)
110
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
  • Evidence of adequate organ function (such as liver, kidneys, etc.)

Exclusion Criteria:

  • Diagnosis of anal cancer
  • Patients who are candidates for surgery
  • Patients who have received previous treatments
  • Pregnant or lactating women
  • History of chronic disease(s) or other serious medical conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00314353
Other Study ID Numbers  ICMJE NSABP FC-BV-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NSABP Foundation Inc
Study Sponsor  ICMJE NSABP Foundation Inc
Collaborators  ICMJE
  • Genentech, Inc.
  • Hoffmann-La Roche
  • International Drug Development Institute
Investigators  ICMJE
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
PRS Account NSABP Foundation Inc
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP