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

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 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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: bevacizumab [Avastin] Drug: Oxaliplatin Drug: Leucovorin Drug: 5-FU Drug: Irinotecan	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 Randomized Phase II Study to Assess the Safety and Resectablity in Patients With Primarily Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving Treatment With 5-FU, Leucovorin, Oxaliplatin and Bevacizumab With or Without Irinotecan as 1st Line Treatment.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin calcium Oxaliplatin Levoleucovorin Irinotecan Irinotecan hydrochloride Bevacizumab

U.S. FDA Resources

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
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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
Active Comparator: 2	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 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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 and <=70 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

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, 28041

Madrid, Spain, 28046

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:	May 23, 2013
Health Authority:	Austria: Ethikkommission

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Bevacizumab

Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013