non-small cell lung cancer non-small cell lung cancer
Conditions
Interventions
Dacomitinib 45mg/day, OD is orally administered until PD or the meeting of discontinuation criteria.
Treatment for skin disorder is carried out from the first day of dacomitinib administration to 8 we
Once a day or twice a day after breakfast and dinner.
[RP02] Heparinoid is applied twice a day (morning and evening)
[RP03] Hydrocortisone butyrate formulation is applied twice a day (morning and even
Sponsors
Takayama Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients are >=20 years old (at the time of providing informed consent) 2. Patients with histolog ically or cytolog ically confirmed non-small cell lung cancer 3. Patients with EGFR mutation positive 4. Patients at a stag e of IIIB/IIIC or IV who are inoperable or who experienced postoperative recurrence 5. No treatment history of dacomitinib 6. Patients with at least 1 measurable lesion according to RECIST v1.1 criteria 7. Patients with performance status (ECOG) of 0-2 8. Patients for whom bone marrow, hepatic, and renal functions have all been confirmed as normal within 2 weeks prior to enrollment according to the following clinical test White blood cell count>= 3.0x10^3/uL -12.0x10^3/uL Neutrophil count >= 1.5x10^3/uL Platelet count >= 100x10^3/uL Hemoglobin >= 9.0 g/dl AST =90% 9. Patients whose following period after prior treatment passed in the planned starting point of administration (eligible from the same day after passed period) Chemotherapy: passed >= 2 weeks after the final administration EGFR-TKI: the next day after the last administration if there is no skin adverse event attributable to ore-treatment of EGFR-TKI or it is improved by = 4 weeks after the day of final radiation 10. Patients providing the written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with active double cancer (synchronous double cancer and metachronous double cancer within 5 years of disease-free interval. However, the lesions correspondent to carcinoma in situ and intramucosal carcinoma curable by topical treatment are excluded) 2. Patients without intention of preventing contraception or whose partner plans to pregnant during the study period 3. Patients who are pregnant, nursing or possibly pregnant 4. Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom. 5. Patients with pulmonary disorders such as interstitial pneumonia, active radiation pneumonitis or drug-induced pneumonia 6. Patients with intestinal paralysis and ileus 7. Patients unable to swallow oral medications 8. Patients with infectious disorder need for intravenous injection of antibacterial drug and antimycotics 9. Patients with spinal cord compression, or unstable brain metastasis accompanying symptoms (however, the participation is possible if neurological function is clinically stable by radical cure treatment and more than 14 days passed after the secession of steroid therapy) 10. Patients with uncontrollable diabetes mellitus(eligible when control is considered good even if insulin is used continuously) 11. Patients with history of hypersensitivity to drugs (skin moisture, sunscreen, topical steroid for external use) and tetracycline agent used in this study 12. Patients who have complications to be clinical problem (Such as sever or uncontrollable systemic disease) uncontrollable hypertension complication of unstable angina pectoris (angina pectoris onset within latest 3 weeks or with progression of spasm) or anamnesis of myocardial infarction within 6 months severe cardiac arrhythmia to need medical treatment sustained watery diarrhoea active bleeding 13. Any other patients who are regarded as unsuitable for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of >= grade 2 skin toxicities during 8 weeks after dacomitinib administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose reduction rate of dacomitinib, safety, progression free survival rate (PFS) | — |
Contacts
Public ContactMasahiro Iwasaku
University Hospital, Kyoto Prefectural University of Medicine
Outcome results
None listed