Evaluation of Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash
- Males and females 18 years of age or older.
- Subjects must have started Tarceva® therapy within three (3) days of trial
- Patients must have signed informed consent prior to registration on study.
- Currently receiving erlotinib therapy at 150 mg per day for locally advanced or
- 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.
- 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