Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID: NCT00006229
Last Updated: 2020-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
774 participants
INTERVENTIONAL
2000-04-04
2009-02-10
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BMS-275291
carboplatin
paclitaxel
rebimastat
Placebo
carboplatin
paclitaxel
Interventions
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carboplatin
paclitaxel
rebimastat
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
* Local or metastatic failure after surgery and/or radiotherapy allowed
* Phase II only:
* At least one measurable lesion
* 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
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/mm\^3
* Platelet count at least 100,000/mm\^3
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 conduction defects, or ventricular arrhythmias requiring medication
* No myocardial infarction within the 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 participation
* No peripheral neuropathy
* No condition (e.g., psychological, geographical) that would preclude study participation
* No prior breast cancer or melanoma
* No other prior malignancy within the past 5 years except carcinoma in situ, basal cell or squamous cell skin cancer, or other cancer that has been curatively treated surgically
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy
* No prior biological response modifiers
* No other concurrent biologic therapy or immunotherapy
Chemotherapy:
* No prior antineoplastic chemotherapy, including intrapleural chemotherapy
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 drugs
* No other concurrent cytotoxic anticancer therapy
* No other investigational drugs during and for 30 days after study
18 Years
120 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Michael Smylie, MD, MB, ChB
Role: STUDY_CHAIR
Cross Cancer Institute at University of Alberta
Locations
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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
Ghent, , 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 Ste. 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
Besançon, , 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
Countries
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References
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Bradbury PA, Twumasi-Ankrah P, Ding K, et al.: The impact of brain metastases on overall survival (OS) in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) clinical trials (CT) in advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-8075, 2009.
Asmis TR, Ding K, Seymour L, Shepherd FA, Leighl NB, Winton TL, Whitehead M, Spaans JN, Graham BC, Goss GD; National Cancer Institute of Canada Clinical Trials Group. Age and comorbidity as independent prognostic factors in the treatment of non small-cell lung cancer: a review of National Cancer Institute of Canada Clinical Trials Group trials. J Clin Oncol. 2008 Jan 1;26(1):54-9. doi: 10.1200/JCO.2007.12.8322.
Wheatley-Price P, Le Maître A, Ding K, et al.: The influence of sex on efficacy, toxicity and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) non-small cell lung cancer (NSCLC) chemotherapy trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-8054, 2008.
Hicks L, Cheung M, Hasan B, et al.: Venous thromboembolism and non-small cell lung cancer: a pooled analysis of National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trials. [Abstract] Blood 110 (11): A-3995, 2007.
Douillard JY, Peschel C, Shepherd F, Paz-Ares L, Arnold A, Davis M, Tonato M, Smylie M, Tu D, Voi M, Humphrey J, Ottaway J, Young K, Vreckem AV, Seymour L. Randomized phase II feasibility study of combining the matrix metalloproteinase inhibitor BMS-275291 with paclitaxel plus carboplatin in advanced non-small cell lung cancer. Lung Cancer. 2004 Dec;46(3):361-8. doi: 10.1016/j.lungcan.2004.05.009.
Leighl NB, Paz-Ares L, Douillard JY, Peschel C, Arnold A, Depierre A, Santoro A, Betticher DC, Gatzemeier U, Jassem J, Crawford J, Tu D, Bezjak A, Humphrey JS, Voi M, Galbraith S, Hann K, Seymour L, Shepherd FA. Randomized phase III study of matrix metalloproteinase inhibitor BMS-275291 in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: National Cancer Institute of Canada-Clinical Trials Group Study BR.18. J Clin Oncol. 2005 Apr 20;23(12):2831-9. doi: 10.1200/JCO.2005.04.044.
Leighl NB, Shepherd F, Paz-Ares L, et al.: Randomized phase II-III study of matrix metalloproteinase inhibitor (MMPI) BMS-275291 in combination with paclitaxel (P) and carboplatin (C) in advanced non-small cell lung cancer (NSCLC): NCIC-CTG BR.18. [Abstract] J Clin Oncol 22 (Suppl 14): A-7038, 626s, 2004.
Other Identifiers
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CAN-NCIC-BR18
Identifier Type: OTHER
Identifier Source: secondary_id
BMS-CA161-003
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068153
Identifier Type: OTHER
Identifier Source: secondary_id
BR18
Identifier Type: -
Identifier Source: org_study_id
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