Lung cancer(adenocarcinoma) Skin disorder(acneiform eruption)
Conditions
Interventions
We plan participation registration of 20 cases to check the condition of a patient of the dermatopathy of EGFR-TKI which is end-point and the mechanism of the anti-inflammatory effect of the minocycli
Sponsors
Wakayama medical university Third department of internal medicine,Oncology center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The patient whom the diagnosis of the pulmonary adenocarcinoma established pathologically. 2) It is confirmed from an organization specimen by an insurance approved method to be EGFR gene variation-positive(exon19 deletion, exon21 L858R variation). 3) In an EGFR-TKI untreated recurrence, progress example, is, a dosage planned patient of gefitinib,erlotinib or afatinib. 4) ECOG performance status 0-1. 5)A main organ (marrow, heart, the lungs, the liver, kidney,etc) does not have a high obstacle. Specifically, as for the marrow function, there are not obstacles more than grade3. As for the cardiac function, the liver function, the renal function, there are not obstacles more than grade2.As the breathing function does not have a interstitial pneumonia and there are not obstacles more than grade2. 6)20 years old or older, the sex does not matter. 7) After enough explanation of examination contents was carried out before final examination registration, a written agreement is provided from a patient.
Exclusion criteria
Exclusion criteria: 1)The patient with history of the EGFR inhibitor treatment. 2)The patient who applied steroid ointment and retinoid or a drug having retinoid-like action to the skin part that was measurement subject within two weeks before clinical trial start. 3)The patient who takes steroid and the minocycline internal use. 4)Complications of a wide range of skin or the patient who has the past. (burn, psoriasis, scleroderma etc.) 5)The patient who received drug-caused skin eruption within two weeks before clinical trial start. 6)A patient with the past of sensitivity to heparin resemblance material component preparation. 7)A patient with hemorrhagic blood disorder(hemophilia, more than grade3 thrombocytopenia, purpura) 8)The patient that it is expected that a few bleeding causes a serious result. 9)A case having serious complications(liver damages more than grade2, renal damage etc.). 10)The patient who internal use is difficult, and has severe diarrhea (more than grade2). 11)The patient with overlap cancer of the activity. 12)A nursing girl and the patient who may be pregnant. The patient who judges that a clinical study doctor (clinical study responsibility doctor,) is inadequate for reasons of others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examination of the mechanism of the anti-inflammatory effect of the minocycline and the pathophysiology of the dermatopathy of EGFR-TKI in biopsy specimens | — |
Secondary
| Measure | Time frame |
|---|---|
| Examination of biomarker of the dermatopathy by a skin physiologic change. Quantification of cytokine and severity(CTCAE ver.4) of the anti-inflammatory effect of the minocycline. Safety after the minocycline internal use. Examination of an effect of EGFR-TKI and skin toxicity. | — |
Countries
Japan
Contacts
Public ContactChigusa Shimono
Wakayama medical university Third department of internal medicine,Oncology center
Outcome results
None listed