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FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer

NCT00145314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 571

Last updated 2011-01-14

No results posted yet for this study

Summary

The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.

Conditions

Interventions

DRUG

FLOX (5-fluorouracil/folinic acid/oxaliplatin)

FLOX every 2nd week

DRUG

FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab

FLOX every 2nd week Cetuximab weekly

DRUG

FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab

FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced. Cetuximab weekly.

Sponsors & Collaborators

  • The Nordic Colorectal Cancer Biomodulation Group

    lead OTHER

Principal Investigators

  • Kjell M. Tveit, MD, PhD · Professor at Ullevål University Hospital, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-05-31
Completion
2010-08-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

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 NCT00145314 on ClinicalTrials.gov