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: Randomizedphase III trial to compare the effectiveness of polyglutamate paclitaxel with that of docetaxel in treating patients who have progressive non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
recurrent non-small cell lung cancer stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer	Drug: docetaxel  Drug: polyglutamate paclitaxel  Procedure: chemotherapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• No cellular diagnosis by sputum cytology alone
• Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable
• 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

Alabama
      Clinical Research Consultants, Incorporated, Hoover,  Alabama,  35216,  United States
Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States
Arkansas
      Highlands Oncology Group - Springdale, Springdale,  Arkansas,  72764,  United States
California
      California Cancer Care, Inc., Greenbrae,  California,  94904-2007,  United States
      California Hematology/Oncology Medical Group, Torrance,  California,  90505,  United States
      Pacific Cancer Medical Center, Incorporated, Anaheim,  California,  92801,  United States
      Synergy Hematology/Oncology Medical Associates, Encino,  California,  91316,  United States
Florida
      Florida Oncology Associates, Jacksonville,  Florida,  32207,  United States
      Hematology Oncology Associates of theTreasure Coast - Port St. Lucie, Port Saint Lucie,  Florida,  34952,  United States
      Northwest Oncology and Hematology Associates, Coral Springs,  Florida,  33065,  United States
Georgia
      Suburban Hematology-Oncology, Snellville,  Georgia,  30078-6782,  United States
Illinois
      Gross Point Medical Center, Skokie,  Illinois,  60077,  United States
Kentucky
      Kentucky Cancer Clinic, Pikeville,  Kentucky,  41501,  United States
      Western Kentucky Hematology/Oncology Group, Paducah,  Kentucky,  42003,  United States
Missouri
      Saint Joseph Oncology, Incorporated, Saint Joseph,  Missouri,  64507,  United States
Montana
      Montana Cancer Specialists, Missoula,  Montana,  59807-7877,  United States
Nevada
      Las Vegas Cancer Center, Las Vegas,  Nevada,  89102,  United States
New Jersey
      Morristown Memorial Hospital, Morristown,  New Jersey,  07962,  United States
      Howell,  New Jersey,  07731,  United States
New Mexico
      New Mexico Oncology-Hematology Consultants, Limited, Albuquerque,  New Mexico,  87109,  United States
New York
      Queens Medical Associates, PC, Fresh Meadows,  New York,  11365,  United States
North Carolina
      Piedmont Oncology Specialist, II, PLLC, Monroe,  North Carolina,  28110,  United States
North Dakota
      Odyssey Research Services, Bismarck,  North Dakota,  58501,  United States
Ohio
      Gabrail Cancer Center - Canton Office, Canton,  Ohio,  44718,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Pennsylvania
      Pennsylvania Oncology Hematology Associates, Philadelphia,  Pennsylvania,  19106,  United States
South Carolina
      Charleston Hematology-Oncology, P.A., Charleston,  South Carolina,  29403,  United States
      Santee Hematology Oncology, Sumter,  South Carolina,  29150,  United States
      Tri County Oncology Associates, Rock Hill,  South Carolina,  29732-1119,  United States
Tennessee
      Family Cancer Center, Collierville,  Tennessee,  38017,  United States
Texas
      Richardson,  Texas,  75080,  United States
      Southwest Regional Cancer Center, Austin,  Texas,  78705,  United States
Virginia
      Danville Hematology and Oncology, Incorporated, Danville,  Virginia,  24541,  United States
      Virginia Oncology Care P.C., Richlands,  Virginia,  24641,  United States
Washington
      Western Washington Medical Group, Everett,  Washington,  98201,  United States

Study chairs or principal investigators

Brenda Garrison,  Study Chair,  PPD   

Study ID Numbers:  CDR0000269907; CTI-PGT302; CWRU-CTI-1503
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054184
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08