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 | Unknown Phase 4

• 1 other identifier: DERMATUX
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer Metastatic

Keywords

Phase IV Study; Metastatic Colorectal Cancer (mCRC; Cetuximab (Erbitux); first-line treatment; acneiform follicular exanthema; rash; vitamin K1

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival rate at 12 months

  12 months

Secondary Outcomes (9)

• Progression-free survival

  up to end of follow-up-phase (36 months)

• ORR

  approximately 12 months

• OS

  The time from regsitration date to the date of death

• Duration until development of acneiforme follicular exanthema >= grade 2

  approximately 12 months

• Development of paronychia

  approximately 12 months

Study Arms (1)

FOLFIRI + Cetuximab

EXPERIMENTAL

Drug: FOLFIRI + Cetuximab

Interventions

FOLFIRI + Cetuximab DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed metastatic colorectal cancer (primary tumor or metastasis)
• Confirmation of KRAS wildtype status
• Confirmation of EGFR-Expression in the tumor
• Stadium IV
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Qualified for an application of FOLFIRI + Cetuximab treatment
• Signed patient informed consent form
• Of either gender and aged 18 years or more
• Estimated lifespan more than 3 months
• Measurable disease according to RECIST 1.1 guidelines. The evaluation has to be max. 4 weeks
• Effective and adequate contraceptive precautions of man or woman in a childbearing potential age (double barrier method)
• Leucocytes ≥ 3,0 x 10\^9/L with neutrophils ≥ 1,5 x 10\^9/L, thrombocytes ≥ 100 x 10\^9/L, haemoglobin ≥ 5,6 mmol/L
• Serum bilirubin ≤ 1,5 x ULN (upper limit of normal)
• ALAT and ASAT ≤ 2,5 x ULN; if metastasis in liver, than ALAT and ASAT ≤ 5 x ULN
• Serum creatinin ≤ 1,5 x ULN

You may not qualify if:

• KRAS-gene mutation
• Confirmation of non-EGFR-Expression
• Prior treatment with an EGRF-receptor inhibitor
• Prior chemotherapy of the mCRC, except (neo-)adjuvant therapy, which had to be ended min. 6 months before recruitment
• Experimental treatment medication within 30 days before recruitment
• Known hypersensitivity against components of the chemotherapy, cetuximab, doxycycline, Reconval K1 or Dermatop
• Rosacea
• Other chronic dermal diseases with development of papula or pustule
• Known lung fibrosis or interstitial pneumonitis or interstitial lung diseases
• keratitis, ulcerative keratitis or severe form of dry eye
• Pregnancy or breast feeding
• Brain metastasis
• Clinical relevant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrollable arrhythmia
• Acute or subacute ileus or chronic colon-inflammation or chronic diarrhea
• Symptomatic peritoneal carcinomatosis

Sponsors & Collaborators

• Dr. Carl Schimanski: lead

Study Sites (1)

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Exanthema

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Carl Christoph Schimanski, PD Dr. med.

  Universitätsmedizin Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 16, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2018
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

DE (1)