TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) - Tabular View

Tracking Information
First Received Date ^ICMJE	February 12, 2004
Last Updated Date	January 10, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00077883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official Title ^ICMJE	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Brief Summary	The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non-Small Cell Lung Cancer
Intervention ^ICMJE	Drug: TLK286, cisplatin
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
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 years of age or older Histologically confirmed non-small cell lung cancer Stage IV or IIIB Measurable disease by RECIST ECOG performance status of 0-1 Adequate liver and renal function Adequate bone marrow reserve Exclusion Criteria: History of bone marrow transplantation or stem cell support Pregnant or lactating women
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	NCT00077883
Responsible Party
Study ID Numbers ^ICMJE	TLK286.2021
Study Sponsor ^ICMJE	Telik
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Telik
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP