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A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

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ClinicalTrials.gov Identifier: NCT01181609
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

July 30, 2010
August 13, 2010
June 4, 2014
July 28, 2014
July 28, 2014
June 2005
May 2010   (Final data collection date for primary outcome measure)
Percentage of Participants Achieving Overall Disease Control (ODC) [ Time Frame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up) ]
ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR 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) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.
Efficacy: Overall control of disease (defined as overall response rate plus stable disease, by RECIST criteria) [ Time Frame: 9 months ]
Complete list of historical versions of study NCT01181609 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving a Best Overall Response of CR or PR [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]
    Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.
  • Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]
    PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.
  • PFS - Time to Event [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]
    PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.
  • Duration of Response [ Time Frame: Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up) ]
    Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.
  • Duration of Overall Disease Control [ Time Frame: Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up) ]
    ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.
  • Overall Survival (OS) - Percentage of Participants With an Event [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]
    Overall survival was defined as the time from start of study treatment to death from any cause.
  • OS - Time to Event [ Time Frame: Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up) ]
    OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.
  • Progression-free survival [ Time Frame: 9 months ]
  • Overall response rate [ Time Frame: 9 months ]
  • Duration of Response [ Time Frame: 9 months ]
  • Duration of overall control of disease [ Time Frame: 9 months ]
  • Overall survival [ Time Frame: 9 months ]
  • Safety profile of Avastin [ Time Frame: 9 months ]
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer
This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
Drug: bevacizumab [Avastin]
5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen
Experimental: 1
Intervention: Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
Same as current
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
  • Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.

Exclusion Criteria:

  • Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
  • Untreated brain metastases, spinal cord compression or primary brain tumours;
  • Pregnant or lactating women;
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
  • Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01181609
ML18559
Not Provided
Not Provided
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