Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

February 24, 2015 updated by: Northwestern University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to determine whether administration of doxycycline affects erlotinib PK
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondarily, this study aims to investigate the relationship between erlotinib AUC and rash severity and to evaluate the efficacy of doxycycline in rash management.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Mario Lacouture, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (Estimate)

December 8, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 24, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEL-120407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Clinical Trials on doxycycline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe