Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00054210
- 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. 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Hematology and Oncology Associates of Alabama
🇺🇸Birmingham, Alabama, United States
Clinical Research Consultants, Inc
🇺🇸Hoover, Alabama, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Synergy Hematology/Oncology Medical Associates
🇺🇸Encino, California, United States
Holy Cross Providence Cancer Center
🇺🇸Mission Hills, California, United States
Clinical Trials and Research Associates, Incorporated
🇺🇸Montebello, California, United States
California Hematology/Oncology Medical Group
🇺🇸Torrance, California, United States
Hematology Oncology, P.C.
🇺🇸Stamford, Connecticut, United States
New Hope Cancer Centers
🇺🇸Hudson, Florida, United States
Omni Healthcare, PA
🇺🇸Melbourne, Florida, United States
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