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| Sponsor: | Northwestern University |
|---|---|
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00803842 |
Purpose
A side effect occurring in a majority of patients taking erlotinib (Tarceva®) consists of a skin rash. Sometimes, symptoms associated with the rash necessitate erlotinib dose reduction or discontinuation. Some physicians have successfully treated the erlotinib-induced rash with doxycycline. At the same time, it has been observed that in patients who develop the erlotinib rash, the cancers respond better to erlotinib treatment. This research study is designed to determine how well doxycycline treats the erlotinib rash and whether doxycycline affects the blood levels of erlotinib.
| Condition | Intervention |
|---|---|
|
Non Small Cell Lung Cancer |
Drug: doxycycline |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Evaluation of Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Current use of agents that are known to be strong inducers or inhibitors of CYTP3A4:
Impaired hepatic function (≤ 30 days before randomization):
Contacts and Locations| Contact: Marcy Urbanich | 312-695-6829 | m-urbanich@northwestern.edu |
| Contact: Jennifer Hensley, MD | 312-695-0287 | j-hensley@northwestern.edu |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Jennifer Hensley, MD 312-695-0287 j-hensley@northwestern.edu | |
| Principal Investigator: Mario Lacouture, MD | |
| Principal Investigator: | Mario Lacouture, MD | Northwestern University |
More Information
| Responsible Party: | Northwestern University ( Mario E. Lacouture, MD ) |
| Study ID Numbers: | MEL-120407 |
| Study First Received: | December 5, 2008 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00803842 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
erlotinib rash supportive care |
|
Thoracic Neoplasms Erlotinib Anti-Infective Agents Respiratory Tract Neoplasms Antiprotozoal Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Antimalarials |
Anti-Bacterial Agents Antiparasitic Agents Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Doxycycline Neoplasms, Glandular and Epithelial |