Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00054184|
Recruitment Status : Unknown
Verified July 2013 by CTI BioPharma.
Recruitment status was: Active, not recruiting
First Posted : February 6, 2003
Last Update Posted : July 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: docetaxel Drug: paclitaxel poliglumex||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study|
|Study Start Date :||January 2003|
|Estimated Primary Completion Date :||December 2013|
|Experimental: Study drug||Drug: docetaxel Drug: paclitaxel poliglumex|
- Saftey [ Time Frame: Baseline to end of treatment ]
- Efficacy [ Time Frame: Basline to EOS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054184
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|Study Chair:||Brenda Garrison||PPD, Incorporated|