Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of gemcitabine or vinorelbine in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Drug: gemcitabine hydrochloride
Drug: paclitaxel poliglumex
Drug: vinorelbine tartrate
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||January 2003|
- 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 regimens.
- Compare the improvement in lung cancer symptoms in patients treated with these regimens.
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054197
|United States, Alabama|
|Cooper Green Hospital|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|Gilroy, California, United States, 95020|
|United States, Florida|
|Northwest Oncology and Hematology Associates|
|Coral Springs, Florida, United States, 33065|
|United States, Illinois|
|Midwest Cancer Research Group, Incorporated|
|Skokie, Illinois, United States, 60077|
|United States, Nevada|
|Medschool Associates North|
|Reno, Nevada, United States, 89502|
|United States, New York|
|New York Oncology Hematology, P.C. - Latham|
|Latham, New York, United States, 12110-0610|
|United States, North Dakota|
|Clinical Research Services|
|Bismarck, North Dakota, United States, 58501|
|United States, South Carolina|
|Charleston Hematology-Oncology, P.A.|
|Charleston, South Carolina, United States, 29403|
|United States, Washington|
|Western Washington Medical Group|
|Everett, Washington, United States, 98201|
|Western Washington Oncology, Incorporated|
|Olympia, Washington, United States, 98502|
|Study Chair:||Meghann Smith||PPD, Incorporated|