Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
- Registration Number
- NCT00006229
- Lead Sponsor
- NCIC Clinical Trials Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 774
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-275291 paclitaxel - Placebo paclitaxel - BMS-275291 carboplatin - BMS-275291 rebimastat - Placebo carboplatin -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (69)
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
AKH Vienna
🇦🇹Vienna (Wien), Austria
Memorial Hospital Cancer Center - Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Servicio De Oncologia
🇪🇸Valencia, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Chelsea Westminster Hospital
🇬🇧London, United Kingdom
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto
🇨🇦Toronto, Ontario, Canada
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Central Georgia Hematology Oncology, P.C.
🇺🇸Macon, Georgia, United States
Lahey Clinic - Burlington
🇺🇸Burlington, Massachusetts, United States
Lungenklinik Hemer
🇩🇪Hemer, Germany
Allgemeines Krankenhaus
🇩🇪Hamburg, Germany
Oncologia Medica - Perugia
🇮🇹Perugia, Italy
Universiteit Gent
🇧🇪Gent, Belgium
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Saint Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Erlanger Health Systems
🇺🇸Chattanooga, Tennessee, United States
Division of Medical Oncology - Vanderbilt
🇺🇸Nashville, Tennessee, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Institut Claudius Regaud
🇫🇷Toulouse, France
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege (Luik), Belgium
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Stadisches Krankenhaus Martha Maria Halle-Dolau
🇩🇪Halle, Germany
Universitaetsspital
🇨ðŸ‡Zurich, Switzerland
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
Algemeen Ziekenhuis Sint-Augustinus
🇧🇪Wilrijk, Belgium
Williamson Medical Center
🇺🇸Franklin, Tennessee, United States
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Vienna (Wien), Austria
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Hopital Avicenne
🇫🇷Bobigny, France
CHR de Grenoble - La Tronche
🇫🇷Grenoble, France
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Ospedale Carlo Forlanini
🇮🇹Rome, Italy
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Medical University of Gdansk
🇵🇱Gdansk, Poland
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
Algoma District Medical Group
🇨🇦Sault Sainte Marie, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Peterborough Oncology Clinic
🇨🇦Peterborough, Ontario, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Hopital de Neuhof
🇫🇷Strasbourg, France
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Marienhospital/Ruhr University Bochum
🇩🇪Herne, Germany
Ospedale Civile San Giovanni e Paolo
🇮🇹Venezia, Italy
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
🇩🇪Munich (Muenchen), Germany
Ospedale San Filippo Neri
🇮🇹Rome, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Vila Nova de Gaia, Portugal
Creighton University Cancer Center
🇺🇸Omaha, Nebraska, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Hotel Dieu Health Sciences Hospital - Niagara
🇨🇦St. Catharines, Ontario, Canada
Charing Cross Hospital
🇬🇧London, England, United Kingdom