Lung Cancer Clinical Trial
Official title:
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
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 which regimen of chemotherapy is more effective in treating stage IIIB, stage IV,
or recurrent non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel
plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage
IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES:
- 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 of 2.
- 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 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.
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