Erlotinib (Tarceva) vs. Standard Chemotherapy (Paclitaxel and Carboplatin) in Patients With Advanced NSCLC and ECOG PS 2 - Tabular View

Tracking Information
First Received Date ^ICMJE	June 15, 2004
Last Updated Date	November 3, 2009
Start Date ^ICMJE	February 2004
Estimated Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 16, 2008)	Preliminary estimates of the magnitude and variability of the efficacy of erlotinib and standard chemotherapy in terms of median progression-free survival, Evaluate the safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00085839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 16, 2008)	Tumor response, Duration of response, Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Erlotinib (Tarceva) vs. Standard Chemotherapy (Paclitaxel and Carboplatin) in Patients With Advanced NSCLC and ECOG PS 2
Official Title ^ICMJE	A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
Brief Summary	The purpose of this study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated NSCLC and an ECOG PS of 2. The study will also evaluate the safety of single-agent erlotnib in this patient population.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Non-small Cell Lung Cancer
Intervention ^ICMJE	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Drug: Combination carboplatin and paclitaxel
Study Arms / Comparison Groups	Active Comparator: Erlotinib tablets administered PO, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy Active Comparator: Paclitaxel 200 mg/m2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
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	Active, not recruiting
Estimated Enrollment ^ICMJE	102
Estimated Completion Date	December 2008
Estimated Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Stage IIIB or IV NSCLC No prior chemotherapy ECOG Performance Status 2 Clinically or radiologically measurable disease per RECIST criteria Exclusion Criteria: Gastro-intestinal abnormalities Any concurrent anticancer therapy Prior treatment with EGFR inhibitors of any kind Other active malignancies Uncontrolled brain metastases Severe abnormalities of the cornea Significant cardiac disease
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	NCT00085839
Responsible Party	Angela Davies, MD, OSI Pharmaceuticals, Inc.
Study ID Numbers ^ICMJE	OSI-774-201, Tarceva Performance Status 2
Study Sponsor ^ICMJE	OSI Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	OSI Pharmaceuticals
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP