CT-2103/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
- Compare the efficacy of polyglutamate paclitaxel (CT-2103) and carboplatin vs
paclitaxel and carboplatin, in terms of duration of overall survival, in patients with
stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status
- Compare the disease control (percentage of patients with no disease progression for at
least 12 weeks) and time to progression in patients treated with these regimens.
- Compare the response rate in patients with measurable disease treated with these
- Compare the improvement in lung cancer symptoms in patients treated with these
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to gender, disease stage (IV vs other), geographic location (US vs Western Europe
and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes and
carboplatin IV over 30 minutes on day 1.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1.
Treatment repeats in both arms every 21 days for 6 courses 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 370 patients (185 per treatment arm) will be accrued for this
study within 13 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Columbia Comprehensive Cancer Care Clinic||Columbia, Missouri 65201|
|Hattiesburg Clinic, P.A.||Hattiesburg, Mississippi 39401|
|Cancer Therapy and Research Center||San Antonio, Texas 78229|
|Silver Cross Hospital||Joliet, Illinois 60432|
|Arizona Clinical Research Center||Tucson, Arizona 85712|
|Hematology Oncology, P.C.||Stamford, Connecticut 06902|
|Bond Clinic||Rolla, Missouri 65401|
|California Hematology/Oncology Medical Group||Torrance, California 90505|
|Flint, Michigan 48532|
|Santee Hematology Oncology||Sumter, South Carolina 29150|
|Clinical Research Consultants, Inc||Hoover, Alabama 35216|
|Family Cancer Center||Collierville, Tennessee 38017|
|Summit Medical Group, P.A.||Summit, New Jersey 07901|
|Rainier Oncology||Puyallup, Washington 98372|
|Hematology Oncology Associates of theTreasure Coast - Port St. Lucie||Port Saint Lucie, Florida 34952|
|Charleston Cancer Center||Charleston, South Carolina 29406|
|Synergy Hematology/Oncology Medical Associates||Encino, California 91316|
|Gross Point Medical Center||Skokie, Illinois 60077|
|Kentucky Cancer Clinic||Pikeville, Kentucky 41501|
|Las Vegas Cancer Center||Las Vegas, Nevada 89102|
|Gabrail Cancer Center - Canton Office||Canton, Ohio 44718|
|Virginia Oncology Care P.C.||Richlands, Virginia 24641|
|Hematology and Oncology Associates of Alabama||Birmingham, Alabama 35243|
|Holy Cross Providence Cancer Center||Mission Hills, California 91345|
|Clinical Trials and Research Associates, Incorporated||Montebello, California 90640|
|New Hope Cancer Centers||Hudson, Florida 34667|
|Omni Healthcare, PA||Melbourne, Florida 32901|
|MetCare Oncology||Ormond Beach, Florida 32174|
|Northwest Georgia Oncology Centers, P.C.||Marietta, Georgia 30060|
|Georgia Cancer Specialists - Tucker||Tucker, Georgia 30084|
|Oklahoma Oncology, Inc. - St. John Campus||Tulsa, Oklahoma 74104|
|Clarksville Regional Hematology/Oncology Group||Clarksville, Tennessee 37043|
|Highline Medical Oncology||Burien, Washington 98166|