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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Astellas Pharma Inc ( OSI Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00072631

First received: November 5, 2003

Last updated: August 6, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 5, 2003
Last Updated Date	August 6, 2012
Start Date ^ICMJE	August 2003
Primary Completion Date	March 2006 (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	Not Provided
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	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Advanced Non Small Cell Lung Cancer Failed Prior Chemotherapy
Intervention ^ICMJE	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash
Study Arm (s)	Experimental: 1 erlotinib Intervention: Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	43
Completion Date	March 2006
Primary Completion Date	March 2006 (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 Number ^ICMJE	NCT00072631
Other Study ID Numbers ^ICMJE	OSI-774-202, Dose to Rash
Has Data Monitoring Committee	No
Responsible Party	Astellas Pharma Inc ( OSI Pharmaceuticals )
Study Sponsor ^ICMJE	OSI Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Astellas Pharma Inc
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top