Non-small cell lung cancer
Conditions
Interventions
concomitant erlotinib and minocycline
erlotinib alone
Sponsors
National Hospital Organization, Thoracic Oncology Network Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically confirmed advanced non-small cell lung cancer (2) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease (3) Intervals after any following treatment; A) Radiation therapy 1) No history of irradiation for lung field 2) More than 12 weeks after the last irradiation for thoracic bone metastasis 3) More than 2 weeks after the last irradiation for non-thoracic region or brain metastasis region. B) Surgical procedure More than 1 week after the last operation (Included last pleurodesis or thoracic drainage). C) Chemotherapy More than 2 weeks wash-out periods after last administration of cytotoxic agent or molucular targeting agent. More than 12 weeks wash-out periods after last administration of hormone therapy. (4) ECOG PS 0-2 (5) Patients who have at least one or more measurable lesion by RECIST (Version1.1). (6) Life expectancy is expected more than 12 weeks . (7) Written informed consent (8) Adequate organ function (9) Females must have a negative pregnancy test
Exclusion criteria
Exclusion criteria: (1) Past medical history or clinically active interstitial lung disease. (2) Concomitant skin disease or history of treatment for skin disease within 4 weeks (3) Patients with symptomatic brain metastasis (4) Uncontrolled ascites, pleural effusion or cardiac effusion. (5) Supra vena cava syndrome. (6) Patients who needs the local therapy such as operation or irradiation for symptom relief or prevention of symptomatic disease. (7) Past medical history of any malignant disease less than 5 years disease free period. (8) Receiving systemic treatment of steroid or immunosuppressant within 2 weeks prior to registration. Taking topical steroid for any skin disease. (9) No medical history of tyrosine kinase inhibitor or anti-EGFR-Abs treatment. (10) Any unresolved toxicities from prior therapy greater than NCI-CTCAE (Ver 4.03) grade 2. (11) Past medical history for hypersensitive for minocycline or erlotinib (12) Contraindication for minocycline or erlotinib. (13) Any of following gastrointestinal disorder; 1) Inability to swallow the formulated product 2) Receiving total parenteral nutrition 3) Malabsorption related past medical procedure 4) Past medical history or active inflamatory bowel disease 14) Past medical history or active severe or uncontrolled comorbidty disease. 15) Judgement by the investigator that the patient should not be participated in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of grade 2 or more rash acneiform within 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL VAS scale for itching safety Time to treatment failure(TTF), Overall survival(OS) Objective response rate(ORR) Disease control rate (DCR) Frequency for dose modification or withdrawal of erlotinib | — |
Countries
Japan
Contacts
Public ContactToshiyuki Kozuki
National Hospital Organization, Shikoku Cancer Center Thoracic oncology and Medicine
Outcome results
None listed