A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
- Compare the tumor response rates (complete and partial response) in patients with
relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with
vs without docetaxel.
- Compare time to progression in patients treated with these regimens.
- Compare the overall and 1-year survival of patients treated with these regimens.
- Compare the safety and tolerability of these regimens in these patients.
- Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional
courses beyond confirmation of CR.
Quality of life is assessed on day 1 of each treatment course (before drug administration)
and at 30 days after the completion of study treatment.
Patients are followed at 30 days and then every 3 months for survival.
PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued
for this study within 1 year.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Joan H. Schiller, MD
University of Wisconsin, Madison
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Veterans Affairs Medical Center - Atlanta (Decatur)||Decatur, Georgia 30033|
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|St. Louis University Hospital Cancer Center||Saint Louis, Missouri 63110|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center||Los Angeles, California 90048|
|Hubert H. Humphrey Cancer Center at North Memorial Medical Center||Robbinsdale, Minnesota 55422-2900|
|University of Miami Sylvester Cancer Center||Miami, Florida 33136|
|Siteman Cancer Center||Saint Louis, Missouri 63110|
|Kansas City Cancer Centers - Central||Kansas City, Missouri 64111|