Erlotinib Hydrochloride in Treating Patients With Previously Treated Non-Small Cell Lung Cancer, Head and Neck Cancer, or Esophageal Cancer and Precancerous Lesions of the Lung



Status:Completed
Conditions:Lung Cancer, Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:40 - 79
Updated:3/30/2013
Start Date:March 2010
End Date:March 2014
Contact:Raymond Bergan, MD
Email:r-bergan@northwestern.edu
Phone:312-908-5284

Use our guide to learn which trials are right for you!

A Phase I Study of Erlotinib in Patients With Premalignant Lesions of the Lung


RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib
hydrochloride in treating patients with previously treated non-small cell lung cancer, head
and neck cancer, or esophageal cancer with precancerous lesions of the lung.


OBJECTIVES:

Primary

- To determine the toxicity and safety of multiple low doses of erlotinib hydrochloride
in patients with a history of previously treated aerodigestive cancer and a recently
diagnosed premalignant lesion of the lung.

Secondary

- To determine the efficacy of each dose level of erlotinib hydrochloride on the
modulation of molecular markers in lung biopsies.

- To determine the significance of the change in expression of primary biomarkers (total
epidermal growth factor receptor [EGFR] and phosphorylated-EGFR [p-EGFR]) between pre-
and post-treatment lung biopsies.

- To determine the significance of the change in expression of secondary biomarkers
(p-Akt, p-Erk, Ki67, and Bcl2).

Tertiary

- To model the responses to treatment by evaluating the pharmacokinetics/pharmacodynamics
of erlotinib hydrochloride, the polymorphisms in the EGFR gene and in genes responsible
for erlotinib hydrochloride metabolism and transport, and the optimal biologic
concentration of erlotinib hydrochloride.

OUTLINE: Patients are stratified according to smoking status (current vs former/never
smokers).

Patients receive oral erlotinib hydrochloride once daily for 90 days in the absence of
disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for correlative biomarker,
pharmacokinetic, and pharmacogenetic studies.

After completion of study treatment, patients are followed up at 30 days.

DISEASE CHARACTERISTICS:

- Diagnosis of aerodigestive cancer (non-small cell lung cancer, head and neck cancer,
or esophageal cancer)

- Completed treatment (surgery, chemotherapy, and/or radiotherapy) ≥ 1 year ago

- No evidence of active or current disease, including carcinoma in situ, as
confirmed by a clinical visit and spiral CT scan within the past 30 days

- Diagnosis of a premalignant lung lesion (metaplasia or dysplasia) on autofluorescence
bronchoscopy (AFB) within the past month

- If bronchoscopy was performed > 1 month before evaluation, patient will be
considered for study enrollment after their next AFB

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- ANC ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Creatinine < 1.5 mg/dL

- Total bilirubin ≤ 2.0 mg/dL

- Alkaline phosphatase ≤ 2.5 times upper limit of normal

- Albumin of ≥ 2.5 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No contraindications for treatment with erlotinib hydrochloride or additional
bronchoscopies

- No life-threatening medical condition that would preclude bronchoscopy, including
acute cardiac failure that is unstable despite medication use, uncontrolled
hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease

- No history of interstitial lung disease

- No history of allergic reactions attributed to erlotinib hydrochloride or a known
hypersensitivity to erlotinib hydrochloride

- No uncontrolled or ongoing illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situation that would limit compliance with
study requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent medications that induce or inhibit the CYP3A4-7 enzymes

- No other concurrent investigational agents
We found this trial at
2
sites
201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials