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Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer

Information source: British Columbia Cancer Agency
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rash

Intervention: minocycline; Lotion (clindamycin 2% /hydrocortisone 1%) (Drug); minocycline (Drug); clindamycin 2% and hydrocortisone 1%, (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: British Columbia Cancer Agency

Official(s) and/or principal investigator(s):
Barb Melosky, MD, Principal Investigator, Affiliation: British Columbia Cancer Agency


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall incidence of rash

Secondary outcome: To investigate if the rash caused by erlotinib is self-limiting

Detailed description: Erlotinib has been shown to prolong survival in NSCLC patients who are no longer candidates for further chemotherapy. In July 2005, erlotinib was approved in Canada for the treatment of patients with locally advanced or metastatic NSCLC, following failure of first or second-line chemotherapy. Erlotinib's side effect profile includes rash. The incidence of rash in clinical trials has

been reported to be approximately 50 - 75%, and has been hypothesised to parallel tumour

response (20). The treatment of rash is controversial and many oncologists believe it is untreatable and self-limiting. The cause of the rash is not well understood but is felt to be a systemic event. Clinical experience of the investigators has suggested that minocycline 100 mg orally given twice-daily for 4 weeks and clindamycin 2% and hydrocortisone 1% topical cream for moderate to severe rash is a successful treatment. The objectives of this trial are to better delineate the rash and its features and to describe an optimal treatment. Since the rash is often facial in distribution and can therefore lead to physical and psychological distress to the patient, a dermatology life quality index will also be completed throughout the study.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Histologically or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage IIIB or stage IV) non-small cell lung cancer. 2. Evidence of disease (measurable disease is not mandatory). 3. 18 years of age or older.

4. ECOG performance status of 0 - 3.

5. 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: 1. A history of another cancer other than basal cell carcinoma or cervical cancer in situ within the past 3 years 2. Prior therapy with any type of cancer growth factor inhibitor (EGFR inhibitor or agent targeting this family of growth factor receptors) 3. Life expectancy of less than 12 weeks. 4. Ongoing toxic effects from prior chemotherapy. 5. Pregnant or lactating women. 6. 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). 7. 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. 8. Ongoing treatment with any inhibitors or inducers of CYP3A4 activity 9. Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease). 10. 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. 11. Unwilling or unable to comply with the protocol for the duration of the study. 12. Patients who have experienced prior hypersensitivity reaction to active ingredients or excipients of the following compounds: erlotinib, minocycline, tetracycline, doxycycline or clindamycin.

Locations and Contacts

Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

BC Cancer Agency - Abbotsford, Abbotsford, British Columbia V2S 0C2, Canada

Burnaby Hospital Regional Cancer Centre, Burnaby, British Columbia V5G 2X6, Canada

BC Cancer Agency - Fraser Valley Centre, Vancouver, British Columbia V3V 1Z2, Canada

BC Cancer Agency Vancouver Centre, Vancouver, British Columbia V5Z 4E6, Canada

BC Cancer Agency - Vancouver Island Centre, Victoria, British Columbia V8R 6V5, Canada

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada

Princess Margaret Hospital, Toronto, Ontario M5G 1Z6, Canada

Additional Information

Starting date: January 2009
Last updated: December 19, 2013

Page last updated: August 20, 2015

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