The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.
Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial, patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial design will be used; if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response, the study will proceed to Stage 2, where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or end of study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Wilshire Oncology Medical Group
La Verne, California, United States
To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel
The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.
Time frame: up to 12 cycles
To estimate the time of progression
The progression is defined as the time fromfirst does of MGd to first eviedence of progression
Time frame: up to 12 cycles
To estimate overall survival
The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel
Time frame: up to 12 cycles
To estimate progression-free survival
Progression-free survival is defined as the time from first does of MGd to the earlier of progression
Time frame: up to 12 cycles
To estimate duration of response (CR + PR)
Duration of response (CR +PR) is defined as the time from the fisrt response to the time of disease progression.
Time frame: Up to 12 cycles
To estimate clinical benefit rate (CR + PR + stable disease [SD])
The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation
Time frame: up to 12 cycles
To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC
All patients who receive at one dose of MGd will be included in the safety summaries and analyses
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University of Rochester
Rochester, New York, United States
Tri-County Hematology & Oncology Associates
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Cancer Specialists of Tidewater
Chesapeake, Virginia, United States
Cancer Centre of Southeastern Ontario
Kingston, Ontario, Canada
Hospital Charles Lemoyne
Greenfield Park, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
...and 12 more locations
Time frame: Up to 12 cycles