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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 (DERMATUX)

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ClinicalTrials.gov Identifier: NCT01315990
Recruitment Status : Active, not recruiting
First Posted : March 16, 2011
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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. 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 or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: FOLFIRI + Cetuximab Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2011
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]
    Progression-free survival rate at 12 months


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to end of follow-up-phase (36 months) ]
  2. ORR [ Time Frame: approximately 12 months ]
    Objective response rate over the entire treatment period

  3. OS [ Time Frame: The time from regsitration date to the date of death ]
    Overall survival time

  4. Duration until development of acneiforme follicular exanthema >= grade 2 [ Time Frame: approximately 12 months ]
    Duration until development of acneiforme follicular exanthema >= grade 2 during treatment-phase

  5. Development of paronychia [ Time Frame: approximately 12 months ]
    Development of paronychia during treatment-phase

  6. Development of skin fissure (hand and foot) [ Time Frame: approximately 12 months ]
    Development of skin fissure (hand and foot) during treatment-phase

  7. Rate of secondary resections of metastasis of liver with a curative approach [ Time Frame: approximately 12 months ]
    Rate of secondary resections of metastasis of liver with a curative approach during treatment-phase

  8. Assessment of safety and tolerability [ Time Frame: approximately 12 months ]
    Assessment of safety and tolerability during treatment phase

  9. Development of acneiforme follicular exanthema >= grade2 [ Time Frame: approximately 12 months ]
    Development of acneiforme follicular exanthema >= grade2 during treatment phase


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315990


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

Responsible Party: Dr. Carl Schimanski, Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01315990     History of Changes
Other Study ID Numbers: DERMATUX
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Exanthema
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Skin Diseases
Cetuximab
Antineoplastic Agents