Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
- Registration Number
- NCT00054184
- Lead Sponsor
- CTI BioPharma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study drug docetaxel - Study drug paclitaxel poliglumex -
- Primary Outcome Measures
Name Time Method Saftey Baseline to end of treatment
- Secondary Outcome Measures
Name Time Method Efficacy Basline to EOS
Trial Locations
- Locations (33)
Clinical Research Consultants, Incorporated
🇺🇸Hoover, Alabama, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Highlands Oncology Group - Springdale
🇺🇸Springdale, Arkansas, United States
Pacific Cancer Medical Center, Incorporated
🇺🇸Anaheim, California, United States
Synergy Hematology/Oncology Medical Associates
🇺🇸Encino, California, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
California Hematology/Oncology Medical Group
🇺🇸Torrance, California, United States
Northwest Oncology and Hematology Associates
🇺🇸Coral Springs, Florida, United States
Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
🇺🇸Port Saint Lucie, Florida, United States
Scroll for more (23 remaining)Clinical Research Consultants, Incorporated🇺🇸Hoover, Alabama, United States