Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer (LUTRAERL)
Rash
About this trial
This is an interventional treatment trial for Rash focused on measuring Rash, Erlotinib, Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage IIIB or stage IV) non-small cell lung cancer.
- Evidence of disease (measurable disease is not mandatory).
- 18 years of age or older.
- ECOG performance status of 0 - 3.
- Written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
- A history of another cancer other than basal cell carcinoma or cervical cancer in situ within the past 3 years
- Prior therapy with any type of cancer growth factor inhibitor (EGFR inhibitor or agent targeting this family of growth factor receptors)
- Life expectancy of less than 12 weeks.
- Ongoing toxic effects from prior chemotherapy.
- Pregnant or lactating women.
- Females of childbearing potential who have a positive or no pregnancy test (pregnancy tests must be obtained within 72 hours before starting therapy). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Male or female patients with reproductive potential who are unwilling to use effective and reliable contraceptive methods throughout the course of the study and for 90 days after the last dose of study medication.
- Ongoing treatment with any inhibitors or inducers of CYP3A4 activity
- Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
- Unwilling or unable to comply with the protocol for the duration of the study.
- Patients who have experienced prior hypersensitivity reaction to active ingredients or excipients of the following compounds: erlotinib, minocycline, tetracycline, doxycycline or clindamycin.
Sites / Locations
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BC Cancer Agency - Abbotsford
- Burnaby Hospital Regional Cancer Centre
- BC Cancer Agency - Fraser Valley Centre
- BC Cancer Agency Vancouver Centre
- BC Cancer Agency - Vancouver Island Centre
- Mount Sinai Hospital
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm 1: Prophylactic Treatment
Arm 2: Reactive Treatment
Arm 3: No Treatment Unless Severe (Grade 3)
Participants 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.
Pts will receive treatment at initiation of rash. Tx is dependent on grading of rash as follows: Grade 1 or 2A: Topical clindamycin 2%, with hydrocortisone 1% in lotion base applied twice daily until resolution of rash by one grade Grade 2B: Topical clindamycin 2%, with hydrocortisone 1% in lotion base applied 2x daily and oral minocycline 100mg 2x daily for a min. of 4 weeks and continuing thereafter, as required, until resolution of rash by 1 grade. Scalp lesions will be treated with a topical clindamycin 2%, triamcinolone acetonide 0.1% soln. Grade 3: Pts will discontinue tx with erlotinib 150mg for 1 week and restart at 100mg once daily. Tx with topical clindamycin 2%, with hydrocortisone 1% in lotion base applied 2x daily and oral minocycline 100mg 2x daily for a min. of 4 weeks and continuing thereafter, as required, until resolution of rash to Grade 1 or 2A. Scalp lesions will be treated with a topical clindamycin 2%, triamcinolone acetonide 0.1% soln.
This is the control group. Patients will be treated only if grade 3 rash develops. For grade 3 rash, treatment will be in accordance with that of Grade 3 rash in Treatment Arm 2.