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Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

NCT00469443 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2010-08-19

No results posted yet for this study

Summary

This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.

Conditions

Interventions

DRUG

Irinotecan

Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles

DRUG

5-Fluorouracil

5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles

DRUG

Leucovorin

Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles

DRUG

Capecitabine

Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles

DRUG

Bevacizumab

Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles

DRUG

Bevacizumab

Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles

DRUG

Irinotecan

Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00469443 on ClinicalTrials.gov