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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006229 |
Purpose
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 paclitaxel and carboplatin are more effective with or without BMS-275291 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: rebimastat |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer |
| Study Start Date: | April 2000 |
OBJECTIVES:
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.
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.
Quality of life is assessed.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 776 patients will be accrued for this study within 27 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
Phase II only:
At least one measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| United States, Georgia | |
| Central Georgia Hematology Oncology, P.C. | |
| Macon, Georgia, United States, 31201 | |
| United States, Hawaii | |
| Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Massachusetts | |
| Lahey Clinic - Burlington | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Nebraska | |
| Creighton University Cancer Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Tennessee | |
| Baptist Regional Cancer Center - Knoxville | |
| Knoxville, Tennessee, United States, 37901 | |
| Division of Medical Oncology - Vanderbilt | |
| Nashville, Tennessee, United States, 37232-5536 | |
| Erlanger Health Systems | |
| Chattanooga, Tennessee, United States, 37403 | |
| Saint Thomas Hospital | |
| Nashville, Tennessee, United States, 37205 | |
| Meharry Medical College | |
| Nashville, Tennessee, United States, 37208-3599 | |
| Memorial Hospital Cancer Center - Chattanooga | |
| Chattanooga, Tennessee, United States, 37404 | |
| Jackson-Madison County General Hospital | |
| Jackson, Tennessee, United States, 38301 | |
| Williamson Medical Center | |
| Franklin, Tennessee, United States, 37068-1600 | |
| Austria | |
| AKH Vienna | |
| Vienna (Wien), Austria, A-1090 | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna (Wien), Austria, A-1090 | |
| Belgium | |
| Algemeen Ziekenhuis Sint-Augustinus | |
| Wilrijk, Belgium, 2610 | |
| Centre Hospitalier Regional de la Citadelle | |
| Liege (Luik), Belgium, 4000 | |
| Universiteit Gent | |
| Gent, Belgium, B-9000 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Peterborough Oncology Clinic | |
| Peterborough, Ontario, Canada, K9H 7B6 | |
| Cancer Care Ontario - Windsor Regional Cancer Centre | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Hotel Dieu Health Sciences Hospital - Niagara | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Humber River Regional Hospital | |
| Weston, Ontario, Canada, M9N 1N8 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Algoma District Medical Group | |
| Sault Sainte Marie, Ontario, Canada, P6B 1Y5 | |
| Royal Victoria Hospital, Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Saint Joseph's Health Centre - Toronto | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Finland | |
| Helsinki University Central Hospital | |
| Helsinki, Finland, FIN-0-0029 | |
| France | |
| Centre Hospitalier Universitaire Bretonneau de Tours | |
| Tours, France, 37044 | |
| CHR de Besancon - Hopital Jean Minjoz | |
| Besancon, France, 25030 | |
| CHR de Grenoble - La Tronche | |
| Grenoble, France, 38043 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Hopital Avicenne | |
| Bobigny, France, 93009 | |
| Hopital de Neuhof | |
| Strasbourg, France, 67091 | |
| Institut Claudius Regaud | |
| Toulouse, France, 31052 | |
| Germany | |
| Marienhospital/Ruhr University Bochum | |
| Herne, Germany, DOH-4-4625 | |
| Klinikum Rechts Der Isar/Technische Universitaet Muenchen | |
| Munich (Muenchen), Germany, D-81675 | |
| Lungenklinik Hemer | |
| Hemer, Germany, D-58675 | |
| Allgemeines Krankenhaus | |
| Hamburg, Germany, DOH-2-1075 | |
| Stadisches Krankenhaus Martha Maria Halle-Dolau | |
| Halle, Germany, 06120 | |
| Italy | |
| Istituto Clinico Humanitas | |
| Rozzano (MI), Italy, 20089 | |
| Oncologia Medica - Perugia | |
| Perugia, Italy, 06122 | |
| Ospedale Carlo Forlanini | |
| Rome, Italy, 00149 | |
| Ospedale Civile San Giovanni e Paolo | |
| Venezia, Italy, 30122 | |
| Ospedale San Filippo Neri | |
| Rome, Italy, 00135 | |
| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Portugal | |
| Centro Hospitalar de Vila Nova de Gaia | |
| Vila Nova de Gaia, Portugal, 4434-502 | |
| Spain | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Universitario Marques de Valdecilla | |
| Santander, Spain, 39008 | |
| Servicio De Oncologia | |
| Valencia, Spain, 46017 | |
| Switzerland | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Universitaetsspital | |
| Zurich, Switzerland, CH-8091 | |
| United Kingdom | |
| Chelsea Westminster Hospital | |
| London, United Kingdom, SW10 9NH | |
| United Kingdom, England | |
| Charing Cross Hospital | |
| London, England, United Kingdom, W6 8RF | |
| Study Chair: | Michael Smylie, MD, MB, ChB | Cross Cancer Institute at University of Alberta |
More Information
| Study ID Numbers: | CDR0000068153, CAN-NCIC-BR18, BMS-CA161-003 |
| Study First Received: | September 11, 2000 |
| Last Updated: | June 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006229 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |