TLK286 in Treating Patients With Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00036920|
Recruitment Status : Completed
First Posted : November 21, 2003
Last Update Posted : June 26, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of TLK286 in treating patients who have advanced non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: canfosfamide hydrochloride||Phase 2|
OBJECTIVES: I. Determine the 12-month survival of patients with advanced non-small cell lung cancer treated with TLK286. II. Determine the overall survival of patients treated with this drug. III. Determine the objective response rate, duration of objective response, time to tumor progression, and disease stabilization in patients treated with this drug. IV. Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter.
PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study within 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study Of TLK286 For The Treatment Of Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||December 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036920
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Mark G. Kris, MD||Memorial Sloan Kettering Cancer Center|