Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dr. Carl Schimanski, Johannes Gutenberg University Mainz Identifier:
First received: March 11, 2011
Last updated: December 17, 2013
Last verified: December 2013

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

Condition Intervention Phase
Colorectal Cancer Metastatic
Drug: FOLFIRI + Cetuximab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Progression-free survival rate at 12 months

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: up to end of follow-up-phase (36 months) ] [ Designated as safety issue: No ]
  • ORR [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
    Objective response rate over the entire treatment period

  • OS [ Time Frame: The time from regsitration date to the date of death ] [ Designated as safety issue: No ]
    Overall survival time

  • Duration until development of acneiforme follicular exanthema >= grade 2 [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
    Duration until development of acneiforme follicular exanthema >= grade 2 during treatment-phase

  • Development of paronychia [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
    Development of paronychia during treatment-phase

  • Development of skin fissure (hand and foot) [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
    Development of skin fissure (hand and foot) during treatment-phase

  • Rate of secondary resections of metastasis of liver with a curative approach [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
    Rate of secondary resections of metastasis of liver with a curative approach during treatment-phase

  • Assessment of safety and tolerability [ Time Frame: approximately 12 months ] [ Designated as safety issue: Yes ]
    Assessment of safety and tolerability during treatment phase

  • Development of acneiforme follicular exanthema >= grade2 [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
    Development of acneiforme follicular exanthema >= grade2 during treatment phase

Estimated Enrollment: 165
Study Start Date: January 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFIRI + Cetuximab 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

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • If applicable a prior operation has to be min. 4 weeks ago, biopsy more than 1 week until initiation of treatment. Wounds of operations had to be completely cured
  • No toxicity of prior treatments

Exclusion Criteria:

  • 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
  • Serious, non-healing wounds, ulcera or bone fractures
  • Uncontrollable arterial hypertension
  • Therapeutic anticoagulation (e.g. therapy with marcumar)
  • Known dihydropyrimidine dehydrogenase deficiency
  • Gilbert-Meulengracht-syndrome
  • Other malignant tumours less than five years old. Exceptions include basocellular carcinoma or an in situ cancer of the cervix uteri if they are curative treated as well as an untreated, locally confined, asymptotic "low risk" (indolent) prostata carcinoma (Stage T ≤ T1-2a, PSA < 15 ng/ml, Gleason-Score ≤ 6 ).
  • Known abuse of narcotic drugs or alcohol
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
  • Any significant concomitant disease that excludes the participation to the study
  • Missing or limited juristic contractual capability
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01315990

Universitätsmedizin Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Dr. Carl Schimanski
Principal Investigator: Carl Christoph Schimanski, PD Dr. med. Universitätsmedizin Mainz
  More Information

No publications provided

Responsible Party: Dr. Carl Schimanski, Principal Investigator, Johannes Gutenberg University Mainz Identifier: NCT01315990     History of Changes
Other Study ID Numbers: DERMATUX
Study First Received: March 11, 2011
Last Updated: December 17, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Johannes Gutenberg University Mainz:
Phase IV Study
Metastatic Colorectal Cancer (mCRC
Cetuximab (Erbitux)
first-line treatment
acneiform follicular exanthema
vitamin K1

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Skin Diseases
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 25, 2015