Status:
WITHDRAWN
Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash
Lead Sponsor:
Northwestern University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 discontinuat...
Eligibility Criteria
Inclusion
- Males and females 18 years of age or older.
- Subjects must have started Tarceva® therapy within three (3) days of trial enrollment.
- Patients must have signed informed consent prior to registration on study.
- Currently receiving erlotinib therapy at 150 mg per day for locally advanced or metastatic NSCLC.
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must utilize barrier methods in combination with spermicidal agents for contraception when engaging in sexual intercourse. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
Exclusion
- Allergy to tetracyclines.
- Use of concurrent agents for papulopustular rash.
- Currently receiving anticancer agents other than erlotinib.
- Inability to interrupt other antibiotic therapy.
- Current use of topical steroids
- Current use of systemic immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine, mycophenolate mofetil)
- Photosensitivity or lupus erythematosus.
- Active gastroesophageal reflux disease.
- Women who have a positive pregnancy test or are lactating by history.
- ECOG performance status ≤3.
- Self report of current smoking or history of smoking within 60 days of screening, or positive urine cotinine test.
- Current use of agents that are known to be strong inducers or inhibitors of CYTP3A4:
- inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfi navir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, grapefruit or grapefruit juice
- inducers: rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and St. John's Wort
- Impaired hepatic function (≤ 30 days before randomization):
- Alkaline phosphatase \> 3x ULN
- Aspartate aminotransferase (AST) \> x ULN
- Alanine aminotransferase (ALT) \> 3 x ULN
- Total Bilirubin \> 1.5 x ULN
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00803842
Start Date
October 1 2008
Last Update
February 26 2015
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