A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00700102
First received: June 17, 2008
Last updated: May 30, 2013
Last verified: May 2013

June 17, 2008
May 30, 2013
February 2006
May 2013   (final data collection date for primary outcome measure)
Overall survival (time from randomization to death of any cause) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00700102 on ClinicalTrials.gov Archive Site
  • Overall survival from time of starting first-line therapy [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (after first progression) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Response rate, tumor assessments according to RECIST criteria [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Overall survival; response rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

This study will evaluate the efficacy and safety of adding Avastin (bevacizumab) to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus Avastin. Patients will be randomized to one of 2 chemotherapy strata. Those in stratum 1 will receive chemotherapy (AIO-IRI, FOLFIRI, CAPIRI or XELIRI) alone, or in combination with Avastin (5mg/kg iv on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle) and those in stratum 2 will receive chemotherapy (FUFOX, FOLFOX, CAPOX or XELOX) alone, or in combination with Avastin (5mg/kg on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    5mg/kg iv on days 1 and 14 of each 4 week cycle, or 7.5mg/kg on days 1 and 22 of each 6 week cycle.
  • Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
    As prescribed
  • Drug: FUFOX, FOLFOX, CAPOX or XELOX
    As prescribed
  • Experimental: Chemotherapy 1 + Avastin
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
  • Experimental: Chemotherapy 2 + Avastin
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: FUFOX, FOLFOX, CAPOX or XELOX
  • Active Comparator: Chemotherapy 1
    Intervention: Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
  • Active Comparator: Chemotherapy 2
    Intervention: Drug: FUFOX, FOLFOX, CAPOX or XELOX

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
821
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >=18 years of age
  • Metastatic colorectal cancer and disease progression
  • Previously treated with first-line chemotherapy plus Avastin
  • ECOG <=2.

Exclusion Criteria:

  • Diagnosis of progression of disease more than 3 months after last Avastin administration
  • First-line patients with progression-free survival in first-line of <3 months
  • Patients receiving less than 3 consecutive months of Avastin in first-line therapy
  • Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
  • Clinically significant cardiovascular disease within 6 months prior to start of study treatment
  • Known CNS disease, except for treated CNS metastases as defined by protocol
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Austria,   Belgium,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Switzerland,   Netherlands,   Norway,   Portugal,   Saudi Arabia,   Spain,   Sweden
 
NCT00700102
ML18147
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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