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Sponsors and Collaborators: |
British Columbia Cancer Agency Hoffmann-La Roche |
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Information provided by: | British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT00473083 |
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.
Condition | Intervention | Phase |
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Rash |
Drug: minocycline; Lotion (clindamycin 2% /hydrocortisone 1%) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | June 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barb Melosky, MD | 604 877-6000 ext 2742 | bmelosky@bccancer.bc.ca |
Canada, British Columbia | |
BC Cancer Agency - Vancouver Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
BC Cancer Agency - Vancouver Island Centre | |
Victoria, British Columbia, Canada, V8R 6V5 | |
BC Cancer Agency - Fraser Valley Centre | |
Vancouver, British Columbia, Canada, V3V 1Z2 |
Principal Investigator: | Barb Melosky, MD | BC Cancer Agency |
Study ID Numbers: | ML21016 |
Study First Received: | May 10, 2007 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00473083 History of Changes |
Health Authority: | Canada: Health Canada |
Rash Erlotinib Lung Cancer |
Anti-Inflammatory Agents Erlotinib Thoracic Neoplasms Clindamycin Minocycline Hydrocortisone Skin Diseases Clindamycin-2-phosphate Cortisol succinate Protein Kinase Inhibitors |
Anti-Bacterial Agents Exanthema Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Hydrocortisone acetate Carcinoma, Non-Small-Cell Lung |
Anti-Inflammatory Agents Thoracic Neoplasms Erlotinib Anti-Infective Agents Respiratory Tract Neoplasms Clindamycin Minocycline Hydrocortisone Molecular Mechanisms of Pharmacological Action Skin Diseases Enzyme Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Anti-Bacterial Agents Protein Synthesis Inhibitors Exanthema Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases |