At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed inoperable, locally advanced, recurrent, or metastatic (stage IIIB or IV) NSCLC
- ✓Evidence of disease (measurable disease not mandatory)
- ✓Age ≥18 years
- ✓ECOG performance status 0-3
- ✕Prior therapy with any EGFR inhibitor or agent targeting growth factor receptors of this family
- ✕History of another cancer (except basal cell carcinoma or cervical cancer in situ) within past 3 years
- ✕Life expectancy less than 12 weeks
- ✕Ongoing toxic effects from prior chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Minocycline, Clindamycin 2% in hydrocortisone 1% lotion, and 2 other interventions for Rash. Completed, enrolled 150 participants across 9 sites.
Detailed Summary
The purpose of this trial is to determine if rash caused by erlotinib can be successfully treated and if so to determine the optimal treatment approach. Hypothesis: Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy with minocycline can prevent occurrence in 50% of these patients. Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80% of patients. Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring treatment with monotherapy intervention.
Study Details
Timeline
Interventions
Patients will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.
Appropriate amounts of clindamycin and hydrocortisone powder are mixed with corresponding amount of Nutraderm® lotion for this mixture. If preferred, the appropriate amount of clindamycin powder can be mixed with Emo-Cort® lotion (already contains hydrocortisone 1%), available in 60 mL bottles.
Erlotinib will be given on an outpatient basis at a fixed dose of either 150 or 100 mg as a single daily oral dose.
Clindamycin 2% in Triamcinolone acetonide 0.1% solution in equal parts propylene glycol and water