Lung Cancer Clinical Trial
Official title:
CT-2103 vs Docetaxel for the Second-Line Treatment of 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. It is not yet known whether polyglutamate paclitaxel is more
effective than docetaxel in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel
with that of docetaxel in treating patients who have progressive non-small cell lung cancer.
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.
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