Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

NCT ID: NCT00803842

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31

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 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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

doxycycline

Doxycycline (the study drug) will be provided to all subjects as 100 mg tablets. They will be allocated enough doxycycline to last them until their next scheduled visit. The doxycycline tablets should be taken orally (only) at a dosage of 100 mg every 12 hours. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. The doxycycline tablets should not be taken with foods that contain calcium. The absorption of doxycycline is reduced when taking bismuth subsalicylate. Duration of study period if 14 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Northwestern University

Principal Investigators

Mario Lacouture, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Other Identifiers

MEL-120407

Identifier Type: -

Identifier Source: org_study_id