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Home > "P" Clinical Trials Conditions > Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer  Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Cell Therapeutics ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaGarrison, Study Chair, PPD
Synergy Hematology/Oncology Medical Associates *Recruiting*
Encino, California, 91316
United States
Recruiting Herbert Duvivier 818-728-8444
Suburban Hematology-Oncology *Recruiting*
Snellville, Georgia, 30078-6782
United States
Recruiting Ravi Sarma 770-979-2828
Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Manuel Modiano 520-290-2510
Gabrail Cancer Center - Canton Office *Recruiting*
Canton, Ohio, 44718
United States
Recruiting Nashat Gabrail 330-492-3345
Kentucky Cancer Clinic *Recruiting*
Pikeville, Kentucky, 41501
United States
Recruiting Hassan Ghazal 606-439-2239
Las Vegas Cancer Center *Recruiting*
Las Vegas, Nevada, 89102
United States
Recruiting Nutan Parikh 702-471-7779
Gross Point Medical Center *Recruiting*
Skokie, Illinois, 60077
United States
Recruiting Edward Kaplan 847-675-3900
Tri County Oncology Associates *Recruiting*
Rock Hill, South Carolina, 29732-1119
United States
Recruiting Kashyap Patel 803-329-7772
Piedmont Oncology Specialist, II, PLLC *Recruiting*
Monroe, North Carolina, 28110
United States
Recruiting Gregory Brouse 704-225-8966
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Nathan Levitan 216-844-3695
Queens Medical Associates, PC *Recruiting*
Fresh Meadows, New York, 11365
United States
Recruiting Barry Kaplan 718-460-2300 ext. 614
Morristown Memorial Hospital *Recruiting*
Morristown, New Jersey, 07962
United States
Recruiting Steven Papish 973-538-5210
Virginia Oncology Care P.C. *Recruiting*
Richlands, Virginia, 24641
United States
Recruiting Madhavan Pillai 276-963-0292
Clinical Research Consultants, Incorporated *Recruiting*
Hoover, Alabama, 35216
United States
Recruiting Luigi Bertoli 205-824-3635
Santee Hematology Oncology *Recruiting*
Sumter, South Carolina, 29150
United States
Recruiting Billy Clowney 803-934-8833
Danville Hematology and Oncology, Inc. *Recruiting*
Danville, Virginia, 24541
United States
Recruiting Timothy Brotherton 434-793-0044
Northwest Oncology and Hematology Associates *Recruiting*
Coral Springs, Florida, 33065
United States
Recruiting Steven Weiss 954-755-1904
Southwest Regional Cancer Center *Recruiting*
Austin, Texas, 78705
United States
Recruiting Robert Kerr 512-421-4100
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie *Recruiting*
Port Saint Lucie, Florida, 34952
United States
Recruiting Nicholas Iannotti 561-335-0066
Western Kentucky Hematology/Oncology Group *Recruiting*
Paducah, Kentucky, 42003
United States
Recruiting Harry Carloss 270-441-4343
Charleston Hematology-Oncology, P.A. *Recruiting*
Charleston, South Carolina, 29403
United States
Recruiting David Ellison 843-577-6957
Florida Oncology Associates *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Yousif Abubakr 904-739-7779
Saint Joseph Oncology, Incorporated *Recruiting*
St. Joseph, Missouri, 64507
United States
Recruiting Vicram Gupta 816-271-1032
California Hematology/Oncology Medical Group *Recruiting*
Torrance, California, 90505
United States
Recruiting Alex Makalinao 310-784-1709
Pacific Cancer Medical Center, Incorporated *Recruiting*
Anaheim, California, 92801
United States
Recruiting Veena Charu 714-999-1465
Family Cancer Center *Recruiting*
Collierville, Tennessee, 38017
United States
Recruiting Donald Gravenor 901-850-0272
California Cancer Care, Inc. *Recruiting*
Greenbrae, California, 94904-2007
United States
Recruiting Peter Eisenberg 415-925-5000
Highlands Oncology Group - Springdale *Recruiting*
Springdale, Arkansas, 72764
United States
Recruiting Joseph Beck 501-751-2100
Pennsylvania Oncology Hematology Associates *Recruiting*
Philadelphia, Pennsylvania, 19106
United States
Recruiting David Mintzer 215-829-6088
Montana Cancer Specialists *Recruiting*
Missoula, Montana, 59807-7877
United States
Recruiting John Trauscht 406-728-5600
Western Washington Medical Group *Recruiting*
Everett, Washington, 98201
United States
Recruiting Peter Jiang 425-258-9388
New Mexico Oncology-Hematology Consultants, Limited *Recruiting*
Albuquerque, New Mexico, 87109
United States
Recruiting James Liebmann 505-243-4039
Odyssey Research Services *Recruiting*
Bismark, North Dakota, 58501
United States
Recruiting Ferdinand Addo 701-250-7355
Additional Information:
Study ID Numbers: CDR0000269907; CTI-PGT302,CWRU-CTI-1503
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054184
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
2. Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
3. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
4. Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
5. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other New Mexico Clinical Trials
Other Albuquerque Clinical Trials
Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
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