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Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

Primary Purpose

Non Small Cell Lung Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

doxycycline

About this trial

This is an interventional supportive care trial for Non Small Cell Lung Cancer focused on measuring erlotinib, rash, supportive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondarily, this study aims to investigate the relationship between erlotinib AUC and rash severity and to evaluate the efficacy of doxycycline in rash management.

Full Information

NCT ID

NCT00803842

First Posted

December 5, 2008

Last Updated

February 24, 2015

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT00803842

Brief Title

Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Investigator left the institution and decided not to continue with the study.

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

erlotinib, rash, supportive care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

doxycycline

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario Lacouture, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Erlotinib Pharmacokinetics During Doxycycline Treatment for Erlotinib-induced Rash

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