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Optimal Control of Liver Metastases From Colorectal Cancer With Cetuximab and Hepatic Artery Infusion of Chemotherapy

NCT00852228 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-12-12

No results posted yet for this study

Summary

The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan, oxaliplatin and 5-fluorouracil).

Conditions

Interventions

DRUG

IV cetuximab

Cetuximab is administered every two weeks at the dose of 500 mg/m² over 2h30 (150 minutes).

DRUG

HAI chronomodulated chemotherapy

Irinotecan (180 mg/m²) on day 2 as a 6 hour infusion, starting at 2:00, with a peak at 5:00 Oxaliplatin (85 mg/m²) in split daily doses for 3 days, starting on day 2. Daily sinusoidal infusion duration will last from 10:15 to 21:45, with peak delivery rate at 16:00. 5-Fluorouracil (2800 mg/m²) in split daily doses for 3 days, alternating with oxaliplatin infusions, starting on day 2. Daily sinusoidal infusions will last from 22:15 to 9:45 , with peak delivery at 4:00. Treatments will be repeated every 2 weeks.

DRUG

HAI conventional chemotherapy

Irinotecan (180 mg/m²) on day 1 as a one hour infusion, then Oxaliplatin (85 mg/m²) on day 1 as a two hour infusion, then 5-Fluorouracil (2800 mg/m²) as a 48 h infusion starting on day 2, after completion of oxaliplatin delivery. Treatments will be repeated every 2 weeks.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Merck Serono International SA

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • CRESGE

    collaborator UNKNOWN

  • Association pour la Recherche sur le Temps Biologique et la Chronothérapie

    lead OTHER

Principal Investigators

  • Francis A. Lévi, M.D., Ph.D. · Paul Brousse Hospital, Villejuif, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-03-31
Completion
2015-12-31

Countries

  • Belgium
  • France
  • Italy
  • Portugal

Study Locations

More Related Trials

Entities

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 NCT00852228 on ClinicalTrials.gov