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

OSI Pharmaceuticals43 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Non Small Cell Lung Cancer Failed Prior Chemotherapy

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute for Drug Development Cancer Therapy and Research Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate

Time frame: 3 years

Secondary Outcomes

Feasibility of correlating objective response rate and duration of response to grade of rash

Time frame: 3 years

Data from ClinicalTrials.gov

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