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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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Overall incidence of rash

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Barb Melosky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Health Canada

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Rash
  • Rash
  • Erlotinib
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Exanthema
  • Lung Neoplasms