Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

NCT00803842 | Withdrawn DMC

• 1 other identifier: MEL-120407
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

erlotinib; rash; supportive care

Outcome Measures

Primary Outcomes (1)

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

  14 days

Secondary Outcomes (1)

• 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

Interventions

doxycycline DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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):

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Exanthema

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mario Lacouture, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Last Updated: February 26, 2015

Record last verified: 2015-02