A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000014780
- Lead Sponsor
- ational Hospital Organization, Thoracic Oncology Network Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 280
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method