Spots Global Cancer Trial Database for Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
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 ID: NCT00006229
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * Compare the overall survival of patients with advanced or metastatic non-small cell lung cancer treated with paclitaxel and carboplatin with or without BMS-275291. * Compare the incidence of grade 2 or higher drug related arthritis, arthralgia and/or myalgia in patients treated with these regimens. (Phase II only) * Compare the objective tumor response rate, time to response, and response duration in patients treated with these regimens. * Compare the nature, severity, and frequency of toxic effects of these regimens in these patients. * Compare the progression free survival of patients treated with these regimens. (Phase III only) * Correlate the expression of serum/plasma and tissue matrix metalloproteinases (MMP) levels and other markers with outcomes and response in patients treated with these regimens. * Compare quality of life of patients treated with these regimens. 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. 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Scripps Clinic, La Jolla, California, United States
Central Georgia Hematology Oncology, P.C., Macon, Georgia, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Carle Cancer Center, Urbana, Illinois, United States
Lahey Clinic - Burlington, Burlington, Massachusetts, United States
Creighton University Cancer Center, Omaha, Nebraska, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Erlanger Health Systems, Chattanooga, Tennessee, United States
Memorial Hospital Cancer Center - Chattanooga, Chattanooga, Tennessee, United States
Williamson Medical Center, Franklin, Tennessee, United States
Jackson-Madison County General Hospital, Jackson, Tennessee, United States
Baptist Regional Cancer Center - Knoxville, Knoxville, Tennessee, United States
Saint Thomas Hospital, Nashville, Tennessee, United States
Meharry Medical College, Nashville, Tennessee, United States
Division of Medical Oncology - Vanderbilt, Nashville, Tennessee, United States
AKH Vienna, Vienna (Wien), , Austria
Allgemeines Krankenhaus der Stadt Wien, Vienna (Wien), , Austria
Universiteit Gent, Gent, , Belgium
Centre Hospitalier Regional de la Citadelle, Liege (Luik), , Belgium
Algemeen Ziekenhuis Sint-Augustinus, Wilrijk, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Royal Victoria Hospital, Barrie, Barrie, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Peterborough Oncology Clinic, Peterborough, Ontario, Canada
Algoma District Medical Group, Sault Sainte Marie, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto, Toronto, Ontario, Canada
Humber River Regional Hospital, Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Helsinki University Central Hospital, Helsinki, , Finland
CHR de Besancon - Hopital Jean Minjoz, Besancon, , France
Hopital Avicenne, Bobigny, , France
CHR de Grenoble - La Tronche, Grenoble, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Hopital de Neuhof, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours, Tours, , France
Stadisches Krankenhaus Martha Maria Halle-Dolau, Halle, , Germany
Allgemeines Krankenhaus, Hamburg, , Germany
Lungenklinik Hemer, Hemer, , Germany
Marienhospital/Ruhr University Bochum, Herne, , Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen, Munich (Muenchen), , Germany
Oncologia Medica - Perugia, Perugia, , Italy
Ospedale San Filippo Neri, Rome, , Italy
Ospedale Carlo Forlanini, Rome, , Italy
Istituto Clinico Humanitas, Rozzano (MI), , Italy
Ospedale Civile San Giovanni e Paolo, Venezia, , Italy
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Medical University of Gdansk, Gdansk, , Poland
Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, , Portugal
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Servicio De Oncologia, Valencia, , Spain
Kantonspital Aarau, Aarau, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Universitaetsspital, Zurich, , Switzerland
Charing Cross Hospital, London, England, United Kingdom
Chelsea Westminster Hospital, London, , United Kingdom
Contact Details
Name: Michael Smylie, MD, MB, ChB
Affiliation: Cross Cancer Institute at University of Alberta
Role: STUDY_CHAIR
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