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Trial record 85 of 436 for:    colon cancer AND Capecitabine

A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

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ClinicalTrials.gov Identifier: NCT01159171
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE July 7, 2010
First Posted Date  ICMJE July 9, 2010
Results First Submitted Date  ICMJE May 20, 2014
Results First Posted Date  ICMJE August 15, 2014
Last Update Posted Date August 15, 2014
Study Start Date  ICMJE January 2006
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]
    Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.
  • Percentage of Participants by Best Overall Response [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]
    Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2010)
Overall response rate (ORR: complete and partial response); tumor assessments by Computer Tomography (CT) scan or by Magnetic Resonance Imaging (MRI) [ Time Frame: 3.5 years ]
Change History Complete list of historical versions of study NCT01159171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • Duration of Response - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]
    Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.
  • Duration of Response [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]
    Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.
  • Duration of Stable Disease - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]
    Duration of stable response (CR, PR, or stable disease [SD]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.
  • Duration of Stable Disease [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]
    Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.
  • Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, every month to end of treatment (up to 24 months) ]
    TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).
  • Time to Treatment Failure [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]
    TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.
  • Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]
    TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.
  • Time to Progression [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]
    TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.
  • Overall Survival (OS) - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]
    OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.
  • Overall Survival [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]
    OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2010)
  • Safety: Adverse events, laboratory parameters [ Time Frame: 3.5 years ]
  • Duration of response (DR); tumor assessments by CT scan or ba MRI [ Time Frame: from response to disease progression ]
  • Time to progression (TTP); tumor assessments by CT scan or by MRI [ Time Frame: from baseline to disease progression ]
  • Overall Survival (OS) [ Time Frame: from baseline to death of any cause ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
Official Title  ICMJE Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer
Brief Summary This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    5 mg/kg intravenously every 14 days
  • Drug: capecitabine [Xeloda]
    1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle
  • Drug: oxaliplatin
    40 mg/m2 iv weekly
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: capecitabine [Xeloda]
  • Drug: oxaliplatin
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2010)
50
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2010)
49
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients >=18 years of age
  • Locally advanced or metastatic colorectal cancer
  • No previous treatment with chemotherapy for metastatic disease
  • Measurable and/or evaluable lesions

Exclusion Criteria:

  • Radiotherapy within 4 weeks before study
  • Untreated brain metastases or primary brain tumors
  • Chronic, daily treatment with high-dose aspirin (>325mg/day)
  • Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ
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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01159171
Other Study ID Numbers  ICMJE ML18523
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2014

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