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Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical research trials and Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer. Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer clinical trial. Subjects frequently get the best healthcare possible for their Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer  Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer 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. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV, or recurrentnon-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of polyglutamate paclitaxel plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Details: OBJECTIVES: - Compare the efficacy of polyglutamate paclitaxel (CT-2103) and carboplatin vs paclitaxel and carboplatin, in terms of duration of overall survival, in patients with stage IIIB or IV or recurrent non-small cell lung cancer who have a performance status of 2. - Compare the disease control (percentage of patients with no disease progression for at least 12 weeks) and time to progression in patients treated with these regimens. - Compare the response rate in patients with measurable disease treated with these regimens. - Compare the improvement in lung cancer symptoms in patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, disease stage (IV vs other), geographic location (US vs Western Europe and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes and carboplatin IV over 30 minutes on day 1. - Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats in both arms every 21 days for 6 courses 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 370 patients (185 per treatment arm) will be accrued for this study within 13 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) meeting 1 of the following criteria: - Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery - Stage IIIB and not a candidate for combined modality therapy - Stage IV - No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology - Cytological diagnosis must be based on the following: - 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 - Measurable or nonmeasurable disease - 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: - Neurologic function stable for 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 2 Life expectancy - Not specified 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) - SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No unstable angina - No myocardial infarction within the past 6 months - Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry Neurologic - See Disease Characteristics - No neuropathy greater than grade 1 - No evidence of unstable neurological symptoms within the past 4 weeks (2 weeks for neurological symptoms due to brain metastases) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide) - No clinically significant active infection - No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer - No other unstable medical conditions - No circumstance that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - No prior systemic biologic agent for lung cancer Chemotherapy - See Disease Characteristics - No prior systemic therapy for lung cancer including radiosensitizing agents Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - No concurrent radiotherapy Surgery - See Disease Characteristics - Recovered from prior major surgery Other - More than 12 weeks since prior participation in any research study or treatment with investigational drugs - Recovered from prior investigational therapy or stable for 4 weeks before study treatment - 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:
MelindaBomar, Study Chair, PPD
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060
United States
Omni Healthcare, PA
Melbourne, Florida, 32901
United States
Kentucky Cancer Clinic
Pikeville, Kentucky, 41501
United States
Santee Hematology Oncology
Sumter, South Carolina, 29150
United States
Hematology and Oncology Associates of Alabama
Birmingham, Alabama, 35243
United States
Georgia Cancer Specialists - Tucker
Tucker, Georgia, 30084
United States
Summit Medical Group, P.A.
Summit, New Jersey, 07901
United States
New Hope Cancer Centers
Hudson, Florida, 34667
United States
Clinical Research Consultants, Inc
Hoover, Alabama, 35216
United States
Rainier Oncology
Puyallup, Washington, 98372
United States
Highline Medical Oncology
Burien, Washington, 98166
United States
Gross Point Medical Center
Skokie, Illinois, 60077
United States
Bond Clinic
Rolla, Missouri, 65401
United States
Clinical Trials and Research Associates, Incorporated
Montebello, California, 90640
United States
California Hematology/Oncology Medical Group
Torrance, California, 90505
United States
Holy Cross Providence Cancer Center
Mission Hills, California, 91345
United States
Clarksville Regional Hematology/Oncology Group
Clarksville, Tennessee, 37043
United States
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, 65201
United States
Synergy Hematology/Oncology Medical Associates
Encino, California, 91316
United States
Cancer Therapy and Research Center
San Antonio, Texas, 78229
United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902
United States
Charleston Cancer Center
Charleston, South Carolina, 29406
United States
MetCare Oncology
Ormond Beach, Florida, 32174
United States
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, 34952
United States
Oklahoma Oncology, Inc. - St. John Campus
Tulsa, Oklahoma, 74104
United States
Silver Cross Hospital
Joliet, Illinois, 60432
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, 39401
United States
Family Cancer Center
Collierville, Tennessee, 38017
United States
Virginia Oncology Care P.C.
Richlands, Virginia, 24641
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Gabrail Cancer Center - Canton Office
Canton, Ohio, 44718
United States
Las Vegas Cancer Center
Las Vegas, Nevada, 89102
United States
Additional Information:
Study ID Numbers: CDR0000269910; CTI-PGT303
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054210
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
2. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
3. Bryostatin 1 Plus Paclitaxel in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer
4. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
5. Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other California Clinical Trials
Other Torrance Clinical Trials
Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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