Lung Cancer Clinical Trial
Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
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.
Full 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 Criteria
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
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There are 35 Locations for this study
Hoover Alabama, 35216, United States
Tucson Arizona, 85712, United States
Springdale Arkansas, 72764, United States
Anaheim California, 92801, United States
Encino California, 91316, United States
Greenbrae California, 94904, United States
Torrance California, 90505, United States
Coral Springs Florida, 33065, United States
Jacksonville Florida, 32207, United States
Port Saint Lucie Florida, 34952, United States
Snellville Georgia, 30078, United States
Skokie Illinois, 60077, United States
Paducah Kentucky, 42003, United States
Pikeville Kentucky, 41501, United States
Saint Joseph Missouri, 64507, United States
Missoula Montana, 59807, United States
Las Vegas Nevada, 89102, United States
Howell New Jersey, 07731, United States
Morristown New Jersey, 07962, United States
Albuquerque New Mexico, 87109, United States
Fresh Meadows New York, 11365, United States
Monroe North Carolina, 28110, United States
Bismarck North Dakota, 58501, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19106, United States
Charleston South Carolina, 29403, United States
Rock Hill South Carolina, 29732, United States
Sumter South Carolina, 29150, United States
Collierville Tennessee, 38017, United States
Austin Texas, 78705, United States
Richardson Texas, 75080, United States
Danville Virginia, 24541, United States
Richlands Virginia, 24641, United States
Everett Washington, 98201, United States
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