CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
- Compare the efficacy of polyglutamate paclitaxel (CT-2103) vs docetaxel as second-line
therapy, in terms of duration of overall survival, in patients with progressive
non-small cell lung cancer.
- Compare the safety and toxicity of these regimens in these patients.
- Compare the disease control (stable disease maintained for at least 12 weeks, partial
response, or complete response) and progression-free survival of patients treated with
- Compare the improvement in lung cancer symptoms in patients treated with these
- Compare the frequency of grade 3 and 4 neurotoxicity, edema, alopecia, and side effects
related to corticosteroids in patients treated with these regimens.
- Determine the percentage of patients who receive at least 4 courses of study treatment.
- Compare the response rate in patients with measurable disease treated with these
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to stage (IV vs other), performance status (0 or 1 vs 2), start of front-line
chemotherapy from randomization (less than 16 weeks vs at least 16 weeks), gender, and prior
taxane therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes on day 1.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 840 patients (420 per treatment arm) will be accrued for this
study within 18 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Morristown Memorial Hospital||Morristown, New Jersey 07962-1956|
|Southwest Regional Cancer Center||Austin, Texas 78705|
|California Cancer Care, Inc.||Greenbrae, California 94904-2007|
|Saint Joseph Oncology, Incorporated||Saint Joseph, Missouri 64507|
|Arizona Clinical Research Center||Tucson, Arizona 85712|
|New Mexico Oncology-Hematology Consultants, Limited||Albuquerque, New Mexico 87109|
|Pennsylvania Oncology Hematology Associates||Philadelphia, Pennsylvania 19107|
|Danville Hematology and Oncology, Incorporated||Danville, Virginia 24541|
|Highlands Oncology Group - Springdale||Springdale, Arkansas 72764|
|Florida Oncology Associates||Orange Park, Florida 32073|
|Charleston Hematology-Oncology, P.A.||Charleston, South Carolina 29403|
|Austin, Texas 78705|
|California Hematology/Oncology Medical Group||Torrance, California 90505|
|Queens Medical Associates, PC||Fresh Meadows, New York 11365|
|Santee Hematology Oncology||Sumter, South Carolina 29150|
|Family Cancer Center||Collierville, Tennessee 38017|
|Hackensack, New Jersey 07601|
|Northwest Oncology and Hematology Associates||Coral Springs, Florida 33065|
|Hematology Oncology Associates of theTreasure Coast - Port St. Lucie||Port Saint Lucie, Florida 34952|
|Odyssey Research Services||Bismarck, North Dakota 58501|
|Clinical Research Consultants, Incorporated||Hoover, Alabama 35216|
|Pacific Cancer Medical Center, Incorporated||Anaheim, California 92801|
|Synergy Hematology/Oncology Medical Associates||Encino, California 91316|
|Suburban Hematology-Oncology||Snellville, Georgia 30078-6782|
|Gross Point Medical Center||Skokie, Illinois 60077|
|Western Kentucky Hematology/Oncology Group||Paducah, Kentucky 42003|
|Kentucky Cancer Clinic||Pikeville, Kentucky 41501|
|Montana Cancer Specialists||Missoula, Montana 59807-7877|
|Las Vegas Cancer Center||Las Vegas, Nevada 89102|
|Piedmont Oncology Specialist, II, PLLC||Monroe, North Carolina 28110|
|Gabrail Cancer Center - Canton Office||Canton, Ohio 44718|
|Tri County Oncology Associates||Rock Hill, South Carolina 29732-1119|
|Virginia Oncology Care P.C.||Richlands, Virginia 24641|
|Western Washington Medical Group||Everett, Washington 98201|