Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00054210|
Recruitment Status : Unknown
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 6, 2003
Last Update Posted : July 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: paclitaxel Drug: paclitaxel poliglumex||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||CT-2103/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study|
|Study Start Date :||January 2003|
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): NCT00054210
Hide Study Locations
|United States, Alabama|
|Hematology and Oncology Associates of Alabama|
|Birmingham, Alabama, United States, 35243|
|Clinical Research Consultants, Inc|
|Hoover, Alabama, United States, 35216|
|United States, Arizona|
|Arizona Clinical Research Center|
|Tucson, Arizona, United States, 85712|
|United States, California|
|Synergy Hematology/Oncology Medical Associates|
|Encino, California, United States, 91316|
|Holy Cross Providence Cancer Center|
|Mission Hills, California, United States, 91345|
|Clinical Trials and Research Associates, Incorporated|
|Montebello, California, United States, 90640|
|California Hematology/Oncology Medical Group|
|Torrance, California, United States, 90505|
|United States, Connecticut|
|Hematology Oncology, P.C.|
|Stamford, Connecticut, United States, 06902|
|United States, Florida|
|New Hope Cancer Centers|
|Hudson, Florida, United States, 34667|
|Omni Healthcare, PA|
|Melbourne, Florida, United States, 32901|
|Ormond Beach, Florida, United States, 32174|
|Hematology Oncology Associates of theTreasure Coast - Port St. Lucie|
|Port Saint Lucie, Florida, United States, 34952|
|United States, Georgia|
|Northwest Georgia Oncology Centers, P.C.|
|Marietta, Georgia, United States, 30060|
|Georgia Cancer Specialists - Tucker|
|Tucker, Georgia, United States, 30084|
|United States, Illinois|
|Silver Cross Hospital|
|Joliet, Illinois, United States, 60432|
|Gross Point Medical Center|
|Skokie, Illinois, United States, 60077|
|United States, Kentucky|
|Kentucky Cancer Clinic|
|Pikeville, Kentucky, United States, 41501|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49503|
|United States, Mississippi|
|Hattiesburg Clinic, P.A.|
|Hattiesburg, Mississippi, United States, 39401|
|United States, Missouri|
|Columbia Comprehensive Cancer Care Clinic|
|Columbia, Missouri, United States, 65201|
|Rolla, Missouri, United States, 65401|
|United States, Nevada|
|Las Vegas Cancer Center|
|Las Vegas, Nevada, United States, 89102|
|United States, New Jersey|
|Summit Medical Group, P.A.|
|Summit, New Jersey, United States, 07901|
|United States, Ohio|
|Gabrail Cancer Center - Canton Office|
|Canton, Ohio, United States, 44718|
|United States, Oklahoma|
|Oklahoma Oncology, Inc. - St. John Campus|
|Tulsa, Oklahoma, United States, 74104|
|United States, South Carolina|
|Charleston Cancer Center|
|Charleston, South Carolina, United States, 29406|
|Santee Hematology Oncology|
|Sumter, South Carolina, United States, 29150|
|United States, Tennessee|
|Clarksville Regional Hematology/Oncology Group|
|Clarksville, Tennessee, United States, 37043|
|Family Cancer Center|
|Collierville, Tennessee, United States, 38017|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Cancer Therapy and Research Center|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Virginia Oncology Care P.C.|
|Richlands, Virginia, United States, 24641|
|United States, Washington|
|Highline Medical Oncology|
|Burien, Washington, United States, 98166|
|Puyallup, Washington, United States, 98372|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Study Chair:||Melinda Bomar||PPD, Incorporated|