Spots Global Cancer Trial Database for Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
Official Title: CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Study ID: NCT00054184
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Suburban Hematology-Oncology, Snellville, Georgia, United States
Gross Point Medical Center, Skokie, Illinois, United States
Western Kentucky Hematology/Oncology Group, Paducah, Kentucky, United States
Kentucky Cancer Clinic, Pikeville, Kentucky, United States
Saint Joseph Oncology, Incorporated, Saint Joseph, Missouri, United States
Montana Cancer Specialists, Missoula, Montana, United States
Las Vegas Cancer Center, Las Vegas, Nevada, United States
, Howell, New Jersey, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
New Mexico Oncology-Hematology Consultants, Limited, Albuquerque, New Mexico, United States
Queens Medical Associates, PC, Fresh Meadows, New York, United States
Piedmont Oncology Specialist, II, PLLC, Monroe, North Carolina, United States
Odyssey Research Services, Bismarck, North Dakota, United States
Gabrail Cancer Center - Canton Office, Canton, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania, United States
Charleston Hematology-Oncology, P.A., Charleston, South Carolina, United States
Tri County Oncology Associates, Rock Hill, South Carolina, United States
Santee Hematology Oncology, Sumter, South Carolina, United States
Family Cancer Center, Collierville, Tennessee, United States
Southwest Regional Cancer Center, Austin, Texas, United States
, Richardson, Texas, United States
Danville Hematology and Oncology, Incorporated, Danville, Virginia, United States
Virginia Oncology Care P.C., Richlands, Virginia, United States
Western Washington Medical Group, Everett, Washington, United States
Contact Details
Name: Brenda Garrison
Affiliation: PPD, Incorporated
Role: STUDY_CHAIR
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