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Skin ToxicityPhase 2DERMIANCT03448731

Skin Toxicity in Patients With Metastatic Colorectal Cancer Treated With Anti-EGFR and Chemotherapy (DERMIA)

A Phase 2 study testing Doxycycline 50Mg Tablet in people with Skin Toxicity, run by Fundacion CRIS de Investigación para Vencer el Cáncer at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical evidence has suggested that sub-antimicrobial doses of doxycycline may have the potential to treat inflammatory lesions of acne. The efficacy of doses below 100 mg/day of doxycycline in the prevention of skin toxicity in patients with treated with Epidermal Growth Factor Receptor (EGFR)-targeted therapies has… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Toxicity
What is being tested?
Doxycycline 50Mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
8 sitesSpain
Study dates
10 May 2018to 6 Apr 2020
Phase
Phase 2
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

  • Man or woman at least 18 years old
  • Capable of understanding, signing and dating an informed consent approved by an Independent Ethics Committee (IEC)
  • Histologically confirmed adenocarcinoma of the colon or rectum in patients with initially unresectable metastatic (M1) disease
  • Wild-type RAS tumour status confirmed before study inclusion at local institution
  • Patients who have a treatment plan based on FOLFOX + anti-EGFR or FOLFIRI + anti-EGFR, as first-line treatment of mCRC
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Adequate bone marrow function: neutrophils ≥1.5 x109/L; platelets ≥100 x109/L; haemoglobin ≥9 g/dL
  • Hepatic, renal and metabolic function as follows: Total bilirubin count ≤1.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <5 x ULN; Renal function, calculated as creatinine clearance or 24-hour creatinine clearance ≥50 mL/min; Magnesium > lower limit of normal (LLN)

Who cannot join

  • History of prior or concurrent central nervous system (CNS) metastases
  • History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥5 years before treatment initiation
  • Known hypersensitivity to tetracyclines
  • Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
  • Prior adjuvant chemotherapy for colorectal cancer terminated less than 6 months before metastatic disease was diagnosed
  • Unresolved toxicities of a previous systemic treatment that, in the opinion of the investigator, cause the patient unfit for inclusion
Show all 27Show fewer
  • Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab), antivascular endothelial growth factor (VEGF) or treatment with small molecule EGFR inhibitors (e.g., erlotinib)
  • Prior hormonal therapy, immunotherapy or approved or experimental antibody/proteins ≤30 days before inclusion.
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT)
  • Treatment for systemic infection within 14 days before the start of study treatment
  • Acute or subacute intestinal occlusion and/or active inflammatory bowel disease or other bowel disease that causes chronic diarrhoea (defined as grade ≥ 2 diarrhoea according to Common Terminology Criteria for Adverse Events (CTCAE)
  • Clinically significant peripheral sensory neuropathy
  • Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment
  • History of Gilbert disease or known dihydropyrimidine deficiency syndrome
  • Recent gastroduodenal ulcer to be active or uncontrolled
  • Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
  • Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
  • Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery
  • History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results.
  • Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
  • Any disorder that compromises the patient's ability to provide written informed consent and/or comply with study procedures
  • Any investigational agent within 30 days prior to inclusion
  • Pregnant or breastfeeding woman
  • Surgery (excluding diagnostic biopsy or placement of a central venous catheter) and/or radiotherapy within 28 days prior to inclusion in the study.
  • Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g. diaphragm plus condoms) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and 1 month for men
  • The patient is unwilling or unable to meet the requirements of the study. Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule. These conditions should be discussed with the patient before inclusion in the trial.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Hospital Punta Europa

    Algeciras

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospital Puerta del Mar

    Cadiz

  • Hospital Puerto Real

    Cadiz

  • Hospital Clinico San Cecilio

    Granada

  • Hospital Juan Ramón Jiménez

    Huelva

  • Hospital de Jerez

    Jerez de la Frontera

  • Hospital Virgen Macarena

    Seville

Other trials in Spain

About this study

Official title: Phase II Clinical Trial of Doxycycline 50 mg or 100 mg Daily for the Prevention of Skin Toxicity in Patients With Metastatic Colorectal Cancer Treated With Anti-EGFR and Chemotherapy

Clinical evidence has suggested that sub-antimicrobial doses of doxycycline may have the potential to treat inflammatory lesions of acne. The efficacy of doses below 100 mg/day of doxycycline in the prevention of skin toxicity in patients with treated with Epidermal Growth Factor Receptor (EGFR)-targeted therapies has never been studied. Therefore, the aim of the present study is to describe the efficacy of doxycycline 50 or 100 mg per day in the prevention of skin toxicity in patients with metastatic Colorectal cancer (mCRC) treated with anti-EGFR in combination with chemotherapy.

Conditions
Skin Toxicity
Being tested
Doxycycline 50Mg Tablet

What participants receive

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

  • Doxycycline 50Mg TabletDrug

    Doxycycline administered p.o once daily at a 50 mg dose for 6 weeks beginning on Day -1

Study groups in NCT03448731
Study groupRoleWhat they receive
DoxycyclineExperimentalDoxycycline 50 mg p.o. daily during 6 weeks
Receives: Drug: Doxycycline 50Mg Tablet

What is being measured

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

  1. Efficacy in the prevention of skin toxicity

    Monitoring of skin toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events

    Measured: During 6-week skin treatment

Secondary outcomes (2)

  1. Quality of life of patients during the treatment

    Change in Dermatology Life Quality Index (DLQI) score

    Measured: Up to 7 weeks

  2. Incidence of Treatment-Emergent Adverse Events

    Number of adverse events per patient

    Measured: Up to 6 weeks

Timeline

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

  1. First posted28 Feb 2018
  2. Study start10 May 2018
  3. Primary completion6 Apr 2020
  4. Study completion6 Apr 2020

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448731
Sponsor's protocol ID
DERMIA
Other IDs
2017-004413-98, 2017
Acronym
DERMIA
Status last verified
Apr 2020
First submitted
19 Feb 2018
Last updated
8 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ramirez-Daffos P, Jimenez-Orozco E, Bolanos M, Gonzalez Astorga B, Rubiales S, Ceballos-Barbancho E, Rodriguez Garcia JM, Reina JJ. A phase 2 study for evaluating doxycycline 50 mg once daily and 100 mg once daily as preemptive treatment for skin toxicity in patients with metastatic colorectal cancer treated with an anti-EGFR and chemotherapy. Support Care Cancer. 2022 Oct;30(10):8081-8088. doi: 10.1007/s00520-022-07254-5. Epub 2022 Jul 1.

    PubMed 35776185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxycycline 50Mg Tablet in people with Skin Toxicity, run by Fundacion CRIS de Investigación para Vencer el Cáncer at 8 sites in Spain.

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 8 inclusion and 27 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: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy in the prevention of skin toxicity (time frame: During 6-week skin treatment). 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 NCT03448731, which also lists 1 linked publication.

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 8 Apr 2020.

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