Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Digestive System Diseases

Exanthema

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Coagulants

Vitamins

Irinotecan

Antibodies

Antibodies, Monoclonal

Cetuximab

Fluorouracil

Folic Acid

Immunoglobulins

Mitogens

Vitamin B Complex

Vitamin K

Vitamin K 1

Antineoplastic Agents, Immunological

Folinic Acid

Menadione

Menaquinone

Naphthoquinone

Phylloquinone

Folate

Vitamin B9

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

FOLFIRI + Cetuximab

Carl Christoph Schimanski, PD Dr. med.

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

Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until

* disease progression
* complete response
* development of status of operability
* an uncontrollable exanthema grade 3 or 4 or
* intolerable toxicity is diagnosed. After study discontinuation or end of treatment, respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1.1) every 12 weeks and at the end of study treatment

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

Non-randomized Phase-IV-study to Investigate the Efficacy of FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Progression-free survival rate at 12 months

Objective response rate over the entire treatment period

Duration until development of acneiforme follicular exanthema \>= grade 2 during treatment-phase

Development of paronychia during treatment-phase

Development of skin fissure (hand and foot) during treatment-phase

Rate of secondary resections of metastasis of liver with a curative approach during treatment-phase

Assessment of safety and tolerability during treatment phase

Development of acneiforme follicular exanthema \>= grade2 during treatment phase

Dr. Carl Schimanski

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Colorectal Canc...	FOLFIRI + Cetux...	18 Years -	Johannes Gutenberg University Mainz
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	Colorectal Canc...	FOLFIRI + Cetux...	18 Years -	Johannes Gutenberg University Mainz

Spots Global Cancer Trial Database for phase iv study