Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 3, 2014
Last verified: November 2014
  Purpose

This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresecta ble liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mF OLFOX-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 neoadj uvant chemotherapy regimens. The anticipated time on study treatment is until su rgery, disease progression, unacceptable toxicity or patient refusal, and the ta rget sample size is <100 individuals.


Condition Intervention Phase
Colorectal Cancer
Drug: 5-FU
Drug: bevacizumab [Avastin]
Drug: Irinotecan
Drug: Leucovorin
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Resection rate of liver metastases after neoadjuvant treatment [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: October 2008
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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: bevacizumab [Avastin]
5mg/kg iv day 1 every 2 weeks
Drug: Leucovorin
400mg/m2 2-hour iv infusion, day 1 every 2 weeks
Drug: Oxaliplatin
85mg/m2 2-hour iv infusion, day 1 every 2 weeks
Active Comparator: 2 Drug: 5-FU
3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
Drug: bevacizumab [Avastin]
5mg/kg iv day 1 every 2 weeks
Drug: Irinotecan
165mg/m2 1-hour iv infusion, day 1 every 2 weeks
Drug: Leucovorin
200mg/m2 2-hour iv infusion, day 1 every 2 weeks
Drug: Oxaliplatin
85mg/m2 2-hour iv infusion, day 1 every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778102

Locations
Austria
Wien, Austria, 1090
France
Bordeaux, France, 33075
Creteil, France, 94010
Le Mans, France, 72037
Lille, France, 59037
Lyon, France, 69373
Montpellier, France, 34298
Villejuif, France, 94804
Spain
San Sebastian, Guipuzcoa, Spain, 20080
Palma de Mallorca, Islas Baleares, Spain, 07198
Santiago de Compostela, La Coruña, Spain, 15706
Girona, Spain, 17007
Madrid, Spain, 28046
Madrid, Spain, 28007
Valencia, Spain, 46026
United Kingdom
London, United Kingdom, WC1E 6DD
Manchester, United Kingdom, M20 4BX
Sutton, United Kingdom, SM2 5PT
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00778102     History of Changes
Other Study ID Numbers: MO18725, 2007-007863-26
Study First Received: October 22, 2008
Last Updated: November 3, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014