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Home > "P" Clinical Trials Conditions > Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer  Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
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 giving paclitaxel and carboplatin with BMS-275291 is more effective than giving paclitaxel and carboplatin alone for non-small cell lung cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic non-small cell lung cancer.
Details: OBJECTIVES: I. Compare the overall survival of patients with advanced or metastatic non-small cell lung cancer when treated with paclitaxel and carboplatin with or without BMS-275291. II. Compare the incidence of grade 2 or higher drug related arthritis, arthralgia and/or myalgia in these patients when treated with these regimens. III. Compare the objective tumor response rate, time to response, and response duration in these patients when treated with these regimens. IV. Compare the nature, severity, and frequency of toxicities of these regimens in these patients. V. Compare the progression free survival of these patients when treated with these regimens. VI. Correlate the expression of tissue matrix metalloproteinases (MMP) levels with outcomes and response in these patients when treated with these regimens. PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to center, disease stage (IIIB vs IV), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 plus oral BMS-275291 daily on days 1-21. Arm II: Patients receive paclitaxel and carboplatin as in arm I plus oral placebo daily on days 1-21. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. BMS-275291 or placebo continues beyond 8 courses in the absence of disease progression. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 700 patients (60 for phase II and 640 for phase III) will be accrued for this study within 2 years.
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 (NSCLC) - Local or metastatic failure following surgery and/or radiotherapy allowed Phase II only: - Measurable disease (At least 20 mm by conventional techniques or 10 mm by spiral CT scan) No known CNS metastases unless asymptomatic and at least 4 weeks since prior corticosteroid therapy --Prior/Concurrent Therapy-- Biologic therapy: - No prior immunotherapy - No prior biological response modifiers - No concurrent biologic therapy or immunotherapy Chemotherapy: - No prior antineoplastic chemotherapy, including intrapleural chemotherapy - No other concurrent cytotoxic anticancer therapy Endocrine therapy: See Disease Characteristics Radiotherapy: - See Disease Characteristics - No prior radiotherapy to study lesion (unless evidence of disease progression) or to 30% or greater of marrow bearing bones - At least 1 week since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 2 weeks since prior major surgery - No concurrent surgery Other: - At least 2 weeks since prior investigational drug - No other investigational drug during and for 30 days after study --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: - Absolute granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 2 times ULN (5 times ULN for liver metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: - No significant cardiac disease - No uncontrolled high blood pressure, unstable angina, congestive heart failure, second or third degree atrioventricular conductions defect, or ventricular arrhythmias requiring medication - No myocardial infarction within past year Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction to drugs containing Cremophor EL - No serious active infection or other underlying medical condition that would preclude study - No peripheral neuropathy - No condition (e.g., psychological, geographical) that would preclude study - No prior breast cancer or melanoma - No other prior malignancy in past 5 years except carcinoma in situ, basal or squamous cell skin cancer, or other cancer that has been curatively treated surgically
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelSmylie, Study Chair, National Cancer Institute of Canada
Ospedale Civile San Giovanni e Paolo
Venezia, , 30122
Italy
Centre Hospitalier Regional de la Citadelle
Liege (Luik), , 4000
Belgium
Hospital Universitario Marques de Valdecilla
Santander, , 39008
Spain
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Central Georgia Hematology Oncology, P.C.
Macon, Georgia, 31201
United States
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
Duke University Medical Center
Durham, North Carolina, 27710
United States
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Algoma District Medical Group
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Marienhospital/Ruhr University Bochum
Herne, , DOH-4-4625
Germany
Hopital de Neuhof
Strasbourg, , 67091
France
Medical University of Gdansk
Gdansk, , 80-211
Poland
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Ospedale Carlo Forlanini
Rome, , 00149
Italy
Saint Thomas Hospital
Nashville, Tennessee, 37205
United States
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Division of Medical Oncology - Vanderbilt
Nashville, Tennessee, 37232-5536
United States
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Universiteit Gent
GENT, , B-9000
Belgium
Meharry Medical College
Nashville, Tennessee, 37208-3599
United States
Charing Cross Hospital
London, England, W6 8RF
United Kingdom
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
CHR de Besancon - Hopital Jean Minjoz
Besancon, , 25030
France
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
United States
Oncologia Medica - Perugia
Perugia, , 06122
Italy
Servicio De Oncologia
Valencia, , 46017
Spain
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , 37044
France
Institut Claudius Regaud
Toulouse, , 31052
France
AKH Vienna
Vienna (Wien), , A-1090
Austria
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Carle Cancer Center
Urbana, Illinois, 61801
United States
Williamson Medical Center
Franklin, Tennessee, 37068-1600
United States
Creighton University Cancer Center
Omaha, Nebraska, 68131-2197
United States
Helsinki University Central Hospital
Helsinki, , FIN-0-0029
Finland
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , 4434-502
Portugal
Stadisches Krankenhaus Martha Maria Halle-Dolau
Halle, , 06120
Germany
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
United States
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Inselspital, Bern
BERN, , CH-3010
Switzerland
Scripps Clinic
La Jolla, California, 92037
United States
Academisch Ziekenhuis Maastricht
Maastricht, , 6202 AZ
Netherlands
Chelsea Westminster Hospital
London, , SW10 9NH
United Kingdom
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich (Muenchen), , D-81675
Germany
Universitaetsspital
Zurich, , CH-8091
Switzerland
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Kantonspital Aarau
AARAU, , 5001
Switzerland
Lungenklinik Hemer
Hemer, , D-58675
Germany
CHR de Grenoble - La Tronche
Grenoble, , 38043
France
Ospedale San Filippo Neri
Rome, , 00135
Italy
Hopital Avicenne
Bobigny, , 93009
France
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
United States
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, 37404
United States
Allgemeines Krankenhaus
Hamburg, , DOH-2-1075
Germany
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , 2610
Belgium
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Istituto Clinico Humanitas
Rozzano (MI), , 20089
Italy
Allgemeines Krankenhaus der Stadt Wien
Vienna (Wien), , A-1090
Austria
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Erlanger Health Systems
Chattanooga, Tennessee, 37403
United States
Additional Information:
Study ID Numbers: CDR0000068153; CAN-NCIC-BR18,BMS-CA161-003
Study Start Date: April 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006229
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer
2. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
3. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
4. Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
5. Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Alberta Clinical Trials
Other Edmonton Clinical Trials
Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer
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