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Colorectal Cancer MetastaticPhase 4DERMATUXNCT01315990

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

A Phase 4 study testing FOLFIRI + Cetuximab in people with Colorectal Cancer Metastatic, run by Dr. Carl Schimanski at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
FOLFIRI + Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteGermany
Study dates
Jan 2011to Mar 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsmedizin Mainz

    Mainz, 55131

Other trials in Germany

About this study

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

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
Read the 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
Being tested
FOLFIRI + Cetuximab
Keywords
Phase IV Study, Metastatic Colorectal Cancer (mCRC, Cetuximab (Erbitux), first-line treatment, acneiform follicular exanthema, rash, vitamin K1
Medical subject headings
Colorectal Neoplasms, Exanthema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFIRI + CetuximabDrug

    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
Study groups in NCT01315990
Study groupRoleWhat they receive
FOLFIRI + CetuximabExperimentalNot described
Receives: Drug: FOLFIRI + Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Progression-free survival rate at 12 months

    Measured: 12 months

Secondary outcomes (9)

  1. Progression-free survival

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

  2. ORR

    Objective response rate over the entire treatment period

    Measured: approximately 12 months

  3. OS

    Overall survival time

    Measured: The time from regsitration date to the date of death

  4. Duration until development of acneiforme follicular exanthema >= grade 2

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

    Measured: approximately 12 months

  5. Development of paronychia

    Development of paronychia during treatment-phase

    Measured: approximately 12 months

  6. Development of skin fissure (hand and foot)

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

    Measured: approximately 12 months

  7. Rate of secondary resections of metastasis of liver with a curative approach

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

    Measured: approximately 12 months

  8. Assessment of safety and tolerability

    Assessment of safety and tolerability during treatment phase

    Measured: approximately 12 months

  9. Development of acneiforme follicular exanthema >= grade2

    Development of acneiforme follicular exanthema >= grade2 during treatment phase

    Measured: approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2015 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01315990
Sponsor's protocol ID
DERMATUX
Acronym
DERMATUX
Status last verified
Dec 2013
First submitted
11 Mar 2011
Last updated
18 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FOLFIRI + Cetuximab in people with Colorectal Cancer Metastatic, run by Dr. Carl Schimanski at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01315990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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