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

Purpose

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.

Condition	Intervention	Phase
Advanced Non Small Cell Lung Cancer Failed Prior Chemotherapy	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)	Phase II

MedlinePlus related topics:

Cancer Lung Cancer Rashes

Drug Information available for:

Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase II, Open-Label, Intra-Patient Dose-Escalation Study of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Prior Chemotherapy

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Feasibility of correlating objective response rate and duration of response to grade of rash [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	August 2003
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072631

Locations


United States, Texas
	Institute for Drug DevelopmentCancer Therapy and Research Center
	San Antonio, Texas, United States, 78229

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

Responsible Party:	OSI Pharmaceuticals, Inc. ( Karsten Witt, MD )
Study ID Numbers:	OSI-774-202, Dose to Rash
First Received:	November 5, 2003
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00072631
Health Authority:	United States: Food and Drug Administration; Netherlands: Ministry of Health

Keywords provided by OSI Pharmaceuticals:

Tarceva

erlotinib

NSCLC

Non-Small Cell Lung Cancer

EGFR

OSI-774

Study placed in the following topic categories:

Erlotinib

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00072631