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

NCT ID: NCT00778102

Last Updated: 2016-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

5-FU

Intervention Type DRUG

Bolus 400mg/m2, day 1 every 2 weeks

5-FU

Intervention Type DRUG

2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks

Leucovorin

Intervention Type DRUG

400mg/m2 2-hour iv infusion, day 1 every 2 weeks

Oxaliplatin

Intervention Type DRUG

85mg/m2 2-hour iv infusion, day 1 every 2 weeks

bevacizumab [Avastin]

Intervention Type DRUG

5mg/kg iv day 1 every 2 weeks

2

Group Type ACTIVE_COMPARATOR

5-FU

Intervention Type DRUG

3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks

Irinotecan

Intervention Type DRUG

165mg/m2 1-hour iv infusion, day 1 every 2 weeks

Leucovorin

Intervention Type DRUG

200mg/m2 2-hour iv infusion, day 1 every 2 weeks

Oxaliplatin

Intervention Type DRUG

85mg/m2 2-hour iv infusion, day 1 every 2 weeks

bevacizumab [Avastin]

Intervention Type DRUG

5mg/kg iv day 1 every 2 weeks

Interventions

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5-FU

Bolus 400mg/m2, day 1 every 2 weeks

Intervention Type DRUG

5-FU

3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks

Intervention Type DRUG

5-FU

2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks

Intervention Type DRUG

Irinotecan

165mg/m2 1-hour iv infusion, day 1 every 2 weeks

Intervention Type DRUG

Leucovorin

400mg/m2 2-hour iv infusion, day 1 every 2 weeks

Intervention Type DRUG

Leucovorin

200mg/m2 2-hour iv infusion, day 1 every 2 weeks

Intervention Type DRUG

Oxaliplatin

85mg/m2 2-hour iv infusion, day 1 every 2 weeks

Intervention Type DRUG

bevacizumab [Avastin]

5mg/kg iv day 1 every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Vienna, , Austria

Site Status

Bordeaux, , France

Site Status

Créteil, , France

Site Status

Le Mans, , France

Site Status

Lille, , France

Site Status

Lyon, , France

Site Status

Montpellier, , France

Site Status

Villejuif, , France

Site Status

Palma de Mallorca, Balearic Islands, Spain

Site Status

Girona, Girona, Spain

Site Status

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Santiago de Compostela, La Coruña, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Valencia, Valencia, Spain

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Sutton, , United Kingdom

Site Status

Countries

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Italy Austria France Spain United Kingdom

References

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Cremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. Online ahead of print.

Reference Type DERIVED
PMID: 32816630 (View on PubMed)

Gruenberger T, Bridgewater J, Chau I, Garcia Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.

Reference Type DERIVED
PMID: 25538173 (View on PubMed)

Other Identifiers

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2007-007863-26

Identifier Type: -

Identifier Source: secondary_id

MO18725

Identifier Type: -

Identifier Source: org_study_id