CT-2103 vs Gemcitabine or Vinorelbine 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) vs gemcitabine or
vinorelbine, 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 of 2.
- Compare the safety of these regimens in these patients.
- 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 on day 1
every 21 days.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 every 28
days OR vinorelbine IV over 6-10 minutes on days 1, 8, and 15 every 21 days.
Treatment repeats in both arms for up to 6 courses in the absence of disease progression or
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
|Midwest Cancer Research Group, Incorporated||Skokie, Illinois 60077|
|New York Oncology Hematology, P.C. - Latham||Latham, New York 12110-0610|
|Charleston Hematology-Oncology, P.A.||Charleston, South Carolina 29403|
|Medical Oncology/Hematology||Gilroy, California 95020|
|Northwest Oncology and Hematology Associates||Coral Springs, Florida 33065|
|Western Washington Medical Group||Everett, Washington 98201|
|Cooper Green Hospital||Birmingham, Alabama 35233|
|Medschool Associates North||Reno, Nevada 89502|
|Clinical Research Services||Bismarck, North Dakota 58501|
|Western Washington Oncology, Incorporated||Olympia, Washington 98502|