CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
OBJECTIVES:
- 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
these regimens.
- Compare the improvement in lung cancer symptoms in patients treated with these
regimens.
- 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
regimens.
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Brenda Garrison
Study Chair
PPD, Incorporated
United States: Federal Government
CDR0000269907
NCT00054184
January 2003
Name | Location |
---|---|
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 |