Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-05

Study Completion Date

2007-03-14

Brief Summary

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The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

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Detailed Description

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Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Conditions

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Advanced Non Small Cell Lung Cancer Failed Prior Chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 erlotinib

Group Type EXPERIMENTAL

Tarceva (Trademark) (erlotinib HCl, OSI-774)

Intervention Type DRUG

Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash

Interventions

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Tarceva (Trademark) (erlotinib HCl, OSI-774)

Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
* Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
* Measurable disease per RECIST criteria.
* Adequate bone marrow, hepatic and renal function.

Exclusion Criteria

* Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
* Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
* Known hypersensitivity to minocycline.
* History of serious cardiac disease that is not controlled.
* Serious eye conditions.
* Prior treatment with inhibitors of EGFR of any kind.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No