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

NCT00778102 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-11-02

Study results available
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Summary

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.

Conditions

Interventions

DRUG

5-FU

Bolus 400mg/m2, day 1 every 2 weeks

DRUG

5-FU

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

DRUG

5-FU

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

DRUG

Irinotecan

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

DRUG

Leucovorin

400mg/m2 2-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

DRUG

bevacizumab [Avastin]

5mg/kg iv day 1 every 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Austria
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778102 on ClinicalTrials.gov