A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00778102
First received: October 22, 2008
Last updated: April 7, 2014
Last verified: April 2014

October 22, 2008
April 7, 2014
October 2008
October 2013   (final data collection date for primary outcome measure)
Resection rate of liver metastases after neoadjuvant treatment [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00778102 on ClinicalTrials.gov Archive Site
  • Histopathological response; relapse-free survival; progression-free survival; overall survival; overall response rate; time to response; surgical safety. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Surgical safety (wound healing complications, bleeding) [ Time Frame: 48hrs, 1 months and 3 months post-durgery for surgical safety ] [ Designated as safety issue: No ]
  • SAEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.
A Multicentre Randomised Phase II Study to Assess the Safety and Resectability in Patients With Initially Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving First-line Treatment Either With mFOLFOX-6 Plus Bevacizumab or FOLFOXIRI Plus Bevacizumab (OLIVIA)

This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
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 day 1 every 2 weeks
  • Drug: Oxaliplatin
    85mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • Drug: Leucovorin
    400mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • Drug: 5-FU
    Bolus 400mg/m2, day 1 every 2 weeks
  • Drug: 5-FU
    2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
  • Drug: Leucovorin
    200mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • Drug: 5-FU
    3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
  • Drug: Irinotecan
    165mg/m2 1-hour iv infusion, day 1 every 2 weeks
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: 5-FU
    • Drug: 5-FU
  • Active Comparator: 2
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: 5-FU
    • Drug: Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • unresectable liver metastasis secondary to cancer of colon or rectum;
  • scheduled for standard first line chemotherapy;
  • ECOG performance score of 0 or 1;
  • condition feasible for major abdominal surgery after first line treatment.

Exclusion Criteria:

  • diagnosis of metastatic disease >3 months prior to study entry;
  • evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of celiac lymph nodes;
  • prior systemic or local treatment of metastatic disease;
  • prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study entry;
  • history or evidence of CNS disease unrelated to cancer.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Spain,   United Kingdom
 
NCT00778102
MO18725, 2007-007863-26
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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