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FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

NCT01315990 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2013-12-18

No results posted yet for this study

Summary

The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.

Further Objectives:

1. Development of acneiforme follicular exanthema \>= grade 2
2. Duration until development of acneiforme follicular exanthema \>= grade 2
3. Development of paronychia
4. Development skin fissure (hand and foot)
5. Objective remission according RECIST 1.1
6. Rate of secondary resections of liver metastasis with a curative approach
7. Assessment of safety and tolerability
8. Overall survival
9. Progression free survival

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

FOLFIRI + Cetuximab

1. Cetuximab (Erbitux® )- Cetuximab is a recombinant IgG1 chimeric monoclonal antibody directed against human epidermal growth factor receptor (EGFR). 2. FOLFIRI regimen Administration Schedule: Cetuximab at a initial dose 400 mg/sqm (first week), then 250 mg/sqm on day 1 and 8 Background Chemotherapy (every two weeks) * Irinotecan 180 mg/m² iv , 90 min on day 1 * Folic acid (racemic) 400 mg/m², 120 min on day 1 * 5-FU 400 mg/m² bolus on day 1 * 5-FU 2400 mg/m² iv over 46 h on day 1 to 2

Sponsors & Collaborators

  • Dr. Carl Schimanski

    lead OTHER

Principal Investigators

  • Carl Christoph Schimanski, PD Dr. med. · Universitätsmedizin Mainz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-03-31
Completion
2018-03-31

Countries

  • Germany

Study Locations

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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 NCT01315990 on ClinicalTrials.gov