Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00803842
• Other study ID #: MEL-120407
• Status: Withdrawn
• Phase: N/A
• First received: December 5, 2008
• Last updated: February 24, 2015
• Start date: October 2008

Study information

• Verified date: February 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to determine whether administration of doxycycline affects erlotinib PK		14 days	No
Secondary	Secondarily, this study aims to investigate the relationship between erlotinib AUC and rash severity and to evaluate the efficacy of doxycycline in rash management.		14 days	No