A phase II study to evaluate prophylactic treatment of dacomitinib-induced dermatologic adverse events in EGFR-mutated advanced non-small cell lung cancer

JRCT ID: jRCTs071190015

Registered date:08/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 06/11/2019
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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 weeks.
[RP01] Oral minocycline (100mg/day) is administered; 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 evening)
[RP04] Difluprednate is applied twice a day (morning and evening)
[RP05] Sun screen is applied before going out (SPF25, PFA >=4 and<8, UVA/UVB protection)

Outcome(s)

• Primary Outcome: Incidence of >= grade 2 skin toxicities during 8 weeks after dacomitinib administration
• Secondary Outcome: Dose reduction rate of dacomitinib, safety, progression free survival rate (PFS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <= 100 IU/L
ALT<= 100 IU/L
Total bilirubin <= 1.5xULN
creatinine <= 1.5xULN
SpO2 (Room air)>=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 <= Grade 1 of skin adverse event
Radiation therapy in the case of chest radical irradiation: passed >= 4 weeks after the day of final radiation
10. Patients providing the written informed consent

Exclude 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.

Related Information

• Primary Sponsor: Takayama Koichi
• Source(s) of Monetary Support: Pfizer Japan Inc.