Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)
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|ClinicalTrials.gov Identifier: NCT00373204|
Recruitment Status : Terminated
First Posted : September 7, 2006
Last Update Posted : July 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Motexafin Gadolinium||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||May 2008|
|Experimental: Xcytrin® (motexafin gadolinium)||
Drug: Motexafin Gadolinium
On Day 1 of each 3 week cycle for up to 12 cycles:
MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour.
Other Name: MGd and Docetaxtel
- To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel [ Time Frame: up to 12 cycles ]The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.
- To estimate the time of progression [ Time Frame: up to 12 cycles ]The progression is defined as the time fromfirst does of MGd to first eviedence of progression
- To estimate overall survival [ Time Frame: up to 12 cycles ]The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel
- To estimate progression-free survival [ Time Frame: up to 12 cycles ]Progression-free survival is defined as the time from first does of MGd to the earlier of progression
- To estimate duration of response (CR + PR) [ Time Frame: Up to 12 cycles ]Duration of response (CR +PR) is defined as the time from the fisrt response to the time of disease progression.
- To estimate clinical benefit rate (CR + PR + stable disease [SD]) [ Time Frame: up to 12 cycles ]The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation
- To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC [ Time Frame: Up to 12 cycles ]All patients who receive at one dose of MGd will be included in the safety summaries and analyses
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): NCT00373204
|Study Chair:||Kishan Pandya, MD||University of Rochester, Rochester, NY, USA|