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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01159171
First received: July 7, 2010
Last updated: July 24, 2014
Last verified: July 2014

July 7, 2010
July 24, 2014
January 2006
July 2010   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01159171 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
  • Safety: Adverse events, laboratory parameters [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
  • Duration of response (DR); tumor assessments by CT scan or ba MRI [ Time Frame: from response to disease progression ] [ Designated as safety issue: No ]
  • Time to progression (TTP); tumor assessments by CT scan or by MRI [ Time Frame: from baseline to disease progression ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: from baseline to death of any cause ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • 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
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: capecitabine [Xeloda]
  • Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01159171
ML18523
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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