Know Cancer

forgot password

Evaluation of Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

18 Years
Not Enrolling
Non Small Cell Lung Cancer

Thank you

Trial Information

Evaluation of Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

Inclusion Criteria:

- 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
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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

The primary objective of this study is to determine whether administration of doxycycline affects erlotinib PK

Outcome Time Frame:

14 days

Safety Issue:


Principal Investigator

Mario Lacouture, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • erlotinib
  • rash
  • supportive care
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms