Lung Cancer Clinical Trial
Official title:
CT-2103 vs Docetaxel for the Second-Line Treatment of Non-Small Cell Lung Cancer (NSCLC): A Phase III Study
Verified date | October 2020 |
Source | CTI BioPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 350 |
Est. completion date | October 2004 |
Est. primary completion date | October 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC) - Documented clinical or radiologic disease progression on or after initial systemic therapy - Must have received 1 prior platinum-based systemic therapy for NSCLC - Measurable or nonmeasurable disease - No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology - 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: - No prior systemic chemotherapy as a radiosensitizer combined with radiotherapy - Obtained stable neurologic function at least 2 weeks before study entry - Off steroid therapy or on a tapering regimen - Recovered from prior therapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Al least 16 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - AST or ALT no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No unstable angina - No myocardial infarction within the past 6 months - No evidence of cardiac conduction abnormalities (e.g., bundle branch block or heart block) unless cardiac status stable for the past 6 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No evidence of unstable neurological symptoms in the past 4 weeks (2 weeks for neurological symptoms due to brain metastases) - No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide) - No other unstable medical conditions - No clinically significant active infection - No neuropathy greater than grade 1 - No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer - No circumstance that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior polyglutamate paclitaxel - No prior docetaxel Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - No concurrent radiotherapy Surgery - See Disease Characteristics - Recovered from prior major surgery Other - Recovered from prior therapy - More than 2 weeks since prior treatment for NSCLC - More than 4 weeks since prior investigational drugs - No other concurrent investigational drugs - No other concurrent systemic antitumor therapy - No concurrent amifostine - Concurrent bisphosphonates allowed |
Country | Name | City | State |
---|---|---|---|
United States | New Mexico Oncology-Hematology Consultants, Limited | Albuquerque | New Mexico |
United States | Pacific Cancer Medical Center, Incorporated | Anaheim | California |
United States | Southwest Regional Cancer Center | Austin | Texas |
United States | Odyssey Research Services | Bismarck | North Dakota |
United States | Gabrail Cancer Center - Canton Office | Canton | Ohio |
United States | Charleston Hematology-Oncology, P.A. | Charleston | South Carolina |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Family Cancer Center | Collierville | Tennessee |
United States | Northwest Oncology and Hematology Associates | Coral Springs | Florida |
United States | Danville Hematology and Oncology, Incorporated | Danville | Virginia |
United States | Synergy Hematology/Oncology Medical Associates | Encino | California |
United States | Western Washington Medical Group | Everett | Washington |
United States | Queens Medical Associates, PC | Fresh Meadows | New York |
United States | California Cancer Care, Inc. | Greenbrae | California |
United States | Clinical Research Consultants, Incorporated | Hoover | Alabama |
United States | Florida Oncology Associates | Jacksonville | Florida |
United States | Las Vegas Cancer Center | Las Vegas | Nevada |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Piedmont Oncology Specialist, II, PLLC | Monroe | North Carolina |
United States | Morristown Memorial Hospital | Morristown | New Jersey |
United States | Western Kentucky Hematology/Oncology Group | Paducah | Kentucky |
United States | Pennsylvania Oncology Hematology Associates | Philadelphia | Pennsylvania |
United States | Kentucky Cancer Clinic | Pikeville | Kentucky |
United States | Hematology Oncology Associates of theTreasure Coast - Port St. Lucie | Port Saint Lucie | Florida |
United States | Virginia Oncology Care P.C. | Richlands | Virginia |
United States | Tri County Oncology Associates | Rock Hill | South Carolina |
United States | Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri |
United States | Gross Point Medical Center | Skokie | Illinois |
United States | Suburban Hematology-Oncology | Snellville | Georgia |
United States | Highlands Oncology Group - Springdale | Springdale | Arkansas |
United States | Santee Hematology Oncology | Sumter | South Carolina |
United States | California Hematology/Oncology Medical Group | Torrance | California |
United States | Arizona Clinical Research Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
CTI BioPharma |
United States,
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