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| Sponsor: | Cell Therapeutics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054210 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: paclitaxel poliglumex |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| 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 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
Cytological diagnosis must be based on the following:
Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Clinical Research Consultants, Inc | |
| Hoover, Alabama, United States, 35216 | |
| Hematology and Oncology Associates of Alabama | |
| Birmingham, Alabama, United States, 35243 | |
| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| California Hematology/Oncology Medical Group | |
| Torrance, California, United States, 90505 | |
| Clinical Trials and Research Associates, Incorporated | |
| Montebello, California, United States, 90640 | |
| Holy Cross Providence Cancer Center | |
| Mission Hills, California, United States, 91345 | |
| Synergy Hematology/Oncology Medical Associates | |
| Encino, California, United States, 91316 | |
| United States, Connecticut | |
| Hematology Oncology, P.C. | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Florida | |
| Hematology Oncology Associates of theTreasure Coast - Port St. Lucie | |
| Port Saint Lucie, Florida, United States, 34952 | |
| MetCare Oncology | |
| Ormond Beach, Florida, United States, 32174 | |
| New Hope Cancer Centers | |
| Hudson, Florida, United States, 34667 | |
| Omni Healthcare, PA | |
| Melbourne, Florida, United States, 32901 | |
| United States, Georgia | |
| Georgia Cancer Specialists - Tucker | |
| Tucker, Georgia, United States, 30084 | |
| Northwest Georgia Oncology Centers, P.C. | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Gross Point Medical Center | |
| Skokie, Illinois, United States, 60077 | |
| Silver Cross Hospital | |
| Joliet, Illinois, United States, 60432 | |
| 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 | |
| Bond Clinic | |
| Rolla, Missouri, United States, 65401 | |
| Columbia Comprehensive Cancer Care Clinic | |
| Columbia, Missouri, United States, 65201 | |
| 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 | |
| Cancer Therapy and Research Center | |
| San Antonio, Texas, United States, 78229 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Virginia | |
| Virginia Oncology Care P.C. | |
| Richlands, Virginia, United States, 24641 | |
| United States, Washington | |
| Highline Medical Oncology | |
| Burien, Washington, United States, 98166 | |
| Rainier Oncology | |
| Puyallup, Washington, United States, 98372 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Study Chair: | Melinda Bomar | PPD, Incorporated |
More Information
| Study ID Numbers: | CDR0000269910, CTI-PGT303 |
| Study First Received: | February 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00054210 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |