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

Tracking Information
First Received Date ^ICMJE	November 5, 2003
Last Updated Date	November 3, 2009
Start Date ^ICMJE	August 2003
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 16, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00072631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 16, 2008)	Feasibility of correlating objective response rate and duration of response to grade of rash [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Only patients with 0 to 1 performance status on the ECOG scale are eligible.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Advanced Non Small Cell Lung Cancer Failed Prior Chemotherapy
Intervention ^ICMJE	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00072631
Responsible Party	Angela Davies, MD, OSI Pharmaceuticals, Inc.
Study ID Numbers ^ICMJE	OSI-774-202, Dose to Rash
Study Sponsor ^ICMJE	OSI Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	OSI Pharmaceuticals
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP