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Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical research trials and Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer  Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine 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: 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 whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine in treating non-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of polyglutamate paclitaxel with that of gemcitabine or vinorelbine 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) vs gemcitabine or vinorelbine, 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 safety of these regimens in these patients. - 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 on day 1 every 21 days. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 every 28 days OR vinorelbine IV over 6-10 minutes on days 1, 8, and 15 every 21 days. Treatment repeats in both arms for up to 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 neurologic symptoms within the past 4 weeks (2 weeks for neurologic 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 chemotherapy 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:
MeghannSmith, Study Chair, PPD
Charleston Hematology-Oncology, P.A. *Recruiting*
Charleston, South Carolina, 29403
United States
Recruiting David Ellison 843-577-6957
Cooper Green Hospital *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Susan Ferguson 205-930-3292
Western Washington Oncology, Incorporated *Recruiting*
Olympia, Washington, 98502
United States
Recruiting Min Kang 360-754-3934
Clinical Research Services *Recruiting*
Bismark, North Dakota, 58501
United States
Recruiting Bipinkumar Amin 701-530-6950
New York Oncology Hematology, P.C. - Latham *Recruiting*
Latham, New York, 12110-0610
United States
Recruiting Charles Weissman 518-786-3122
Nevada Medical Group-Internal Medicine *Recruiting*
Reno, Nevada, 89502
United States
Recruiting Frederick MacKintosh 775-784-7500
Medical Oncology/Hematology *Recruiting*
Gilroy, California, 95020
United States
Recruiting Ronald Yanagihara 408-847-6191
Northwest Oncology and Hematology Associates *Recruiting*
Coral Springs, Florida, 33065
United States
Recruiting Steven Weiss 954-755-1904
Midwest Cancer Research Group, Incorporated *Recruiting*
Skokie, Illinois, 60077
United States
Recruiting Ira Oliff 847-673-1999
Western Washington Medical Group *Recruiting*
Everett, Washington, 98201
United States
Recruiting Peter Jiang 425-258-9388
Additional Information:
Study ID Numbers: CDR0000269908; CTI-PGT304
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054197
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
2. Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
4. Bryostatin 1 Plus Paclitaxel in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer
5. Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Washington Clinical Trials
Other Everett Clinical Trials
Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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