Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
NCT ID: NCT00054184
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
350 participants
INTERVENTIONAL
2003-01-31
2004-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study drug
docetaxel
paclitaxel poliglumex
Interventions
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docetaxel
paclitaxel poliglumex
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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CTI BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Brenda Garrison
Role: STUDY_CHAIR
PPD, Incorporated
Locations
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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 Township, 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
Countries
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Other Identifiers
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CDR0000269907
Identifier Type: REGISTRY
Identifier Source: secondary_id
CWRU-CTI-1503
Identifier Type: -
Identifier Source: secondary_id
CTI-PGT302
Identifier Type: -
Identifier Source: org_study_id
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