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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Rashes

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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:	43
Study Start Date:	August 2003
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 erlotinib	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 Development Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

No publications provided

Responsible Party:	Clinical Trials Registry, Astellas Pharma Global Develoment
ClinicalTrials.gov Identifier:	NCT00072631 History of Changes
Other Study ID Numbers:	OSI-774-202, Dose to Rash
Study First Received:	November 5, 2003
Last Updated:	November 21, 2011
Health Authority:	United States: Food and Drug Administration; Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by OSI Pharmaceuticals:

Tarceva
erlotinib
NSCLC

Non-Small Cell Lung Cancer
EGFR
OSI-774

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012