Status:
COMPLETED
Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Rash
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00473083
Start Date
January 1 2009
End Date
August 1 2013
Last Update
April 4 2017
Active Locations (9)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
BC Cancer Agency - Abbotsford
Abbotsford, British Columbia, Canada, V2S 0C2
4
Burnaby Hospital Regional Cancer Centre
Burnaby, British Columbia, Canada, V5G 2X6