Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer
Information source: British Columbia Cancer Agency
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rash
Intervention: minocycline; Lotion (clindamycin 2% /hydrocortisone 1%) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: British Columbia Cancer Agency Official(s) and/or principal investigator(s):
Barb Melosky, MD, Principal Investigator, Affiliation: British Columbia Cancer Agency
Overall contact:
Barb Melosky, MD, Phone: 604 877-6000, Ext: 2742, Email: bmelosky@bccancer.bc.ca
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.
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Barb Melosky, MD, Phone: 604 877-6000, Ext: 2742, Email: bmelosky@bccancer.bc.ca
BC Cancer Agency - Vancouver Island Centre, Victoria, British Columbia V8R 6V5, Canada; Not yet recruiting
Anderson Helen, MD, Principal Investigator
BC Cancer Agency - Fraser Valley Centre, Vancouver, British Columbia V3V 1Z2, Canada; Recruiting
Kevin Jasas, MD, Principal Investigator
BC Cancer Agency Vancouver Centre, Vancouver, British Columbia V5Z 4E6, Canada; Recruiting
Barb Melosky, MD, Phone: 604-877-6000, Ext: 2017, Email: bmelosky@bccancer.bc.ca
Barb Melosky, MD, Principal Investigator
Janessa Laskin, MD, Sub-Investigator
Nevin Murray, MD, Sub-Investigator
Cheryl Ho, MD, Sub-Investigator
Additional Information
Starting date: January 2009
Last updated: October 14, 2009
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