Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED) - Tabular View

Tracking Information
First Received Date ^ICMJE	December 4, 2002
Last Updated Date	May 31, 2006
Start Date ^ICMJE	November 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00050336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)
Official Title ^ICMJE	A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin Vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
Brief Summary	The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small-Cell Lung Metastases, Neoplasm
Intervention ^ICMJE	Drug: Lonafarnib (SARASAR)
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	Terminated
Enrollment ^ICMJE	800
Completion Date	August 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol. Age greater than or equal to 18 years old ECOG performance status of 0 to 1 Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified. Meets protocol requirements for specified laboratory values Written informed consent Appropriate use of effective contraception if of childbearing potential Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease Exclusion Criteria: Prior chemotherapy for any stage of NSCLC Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy Concurrent treatment or treatment within the last 2 years for any other malignancy Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication) Medical conditions that would interfere with taking oral medications Patients with bone metastases as the only site of disease Pregnant or nursing women Known HIV positivity or AIDS-related illness Patients with significant QTc prolongation at baseline
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

Administrative Information
NCT ID ^ICMJE	NCT00050336
Responsible Party
Study ID Numbers ^ICMJE	P01901
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP