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Vinorelbine in Treating Patients With Stage IIIB or Stage IV 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 using a real mD. We aren't mDs. Always confer with your physician on Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): GlaxoSmithKline ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: I. Compare the safety and efficacy of oral versus intravenous vinorelbine in patients with stage IIIB or IV non-small cell lung cancer. II. Compare the quality of life of these patients treated with these regimens. III. Compare the pharmacokinetics of these treatment regimens in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vinorelbine weekly. Arm II: Patients receive vinorelbine IV over 10 minutes weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed several times during treatment and 4 weeks after treatment. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A maximum of 195 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer not amenable to combination chemotherapy, curative surgery, or radiotherapy - Bidimensionally measurable disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunologic therapy; At least 7 days since prior hematopoietic growth factors or other blood products - Chemotherapy: See Disease Characteristics; No prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 28 days since prior radiotherapy - Surgery: See Disease Characteristics; At least 14 days since prior surgery - Other: No other concurrent anticancer therapy; At least 28 days since prior investigational device or drug; No other concurrent investigational device or drug --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: At least 12 weeks - Hematopoietic: Granulocyte count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 11 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT less than 2.5 times ULN; Alkaline phosphatase less than 5 times ULN (except in cases of bone or liver metastases) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No unstable or uncontrolled cardiac disease - Pulmonary: No history of recurrent aspiration pneumonitis in past 3 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 9 days after study; Able to swallow capsules intact No active infection in past 14 days; No unstable or uncontrolled medical conditions; No prior malignancy in past 5 years except basal cell skin cancer or carcinoma in situ of the cervix; No history of peripheral neuropathy with severity greater than CALGB grade 1
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TessDelacruz, Study Chair, GlaxoSmithKline
West Clinic, P.C.
Memphis, Tennessee, 38117
United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510-4844
United States
Medical Group of Texas
Dallas, Texas, 75243
United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Wilshire Oncology Medical Center
Pomona, California, 91767
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
MultiCare Hematolgy/Oncology Clinic
Tacoma, Washington, 98405
United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, 27609
United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48909
United States
West Florida Cancer Institute - Pensacola
Pensacola, Florida, 32514
United States
Medical Oncology, LLC
Baton Rouge, Louisiana, 70808
United States
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
Northern NJ Cancer Associates
Hackensack, New Jersey, 07601
United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410
United States
Cancer Care Consultants of Northern California
Redding, California, 96009-3100
United States
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
United States
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, 72703
United States
Office of Hal Gerstein
Great Neck, New York, 11022
United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Washington University Barnard Cancer Center
St. Louis, Missouri, 63110
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Veterans Affairs Medical Center - Northport
Northport, New York, 11768
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
Mercy Oncology-Hematology Limited
St. Louis, Missouri, 63141
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
Saint Vincents Comprehensive Breast Center
New York City, New York, 10011
United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913
United States
HillCrest Hospital
Mayfield Heights, Ohio, 44124
United States
NorthBay Healthcare System
Fairfield, California, 94533
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Memphis Cancer Center
Memphis, Tennessee, 38119
United States
Berkshire Physicians and Surgeons, P.C.
Pittsfield, Massachusetts, 01201
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Lovelace Health Systems
Albuquerque, New Mexico, 87108
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Office of Luis Alberto Meza
Lafayette, Louisiana, 70503
United States
St. Luke's Hospital
Duluth, Minnesota, 55805
United States
Office of Janak K. Choksi
Burlington, North Carolina, 27216
United States
Providence Hospital Cancer Center
Southfield, Michigan, 48075
United States
South Bend Clinic and SurgiCenter
South Bend, Indiana, 46634
United States
Additional Information:
Study ID Numbers: CDR0000067897; GW-VINA2004
Study Start Date: April 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005865
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
2. SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
3. T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
4. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
5. Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Pittsfield Clinical Trials
Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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