Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer

NCT00006229 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: BR18CAN-NCIC-BR18BMS-CA161-003CDR0000068153
• Study Type: interventional
• Target: 774
• Locations: 14 countries
• Sites: 69

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Study Arms (2)

BMS-275291

EXPERIMENTAL

Drug: carboplatin; Drug: paclitaxel; Drug: rebimastat

Placebo

PLACEBO COMPARATOR

Drug: carboplatin; Drug: paclitaxel

Interventions

carboplatin DRUG

BMS-275291; Placebo

paclitaxel DRUG

BMS-275291; Placebo

rebimastat DRUG

BMS-275291

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (69)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Central Georgia Hematology Oncology, P.C.

Macon, Georgia, 31201, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Lahey Clinic - Burlington

Burlington, Massachusetts, 01805, United States

Location

Creighton University Cancer Center

Omaha, Nebraska, 68131-2197, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

Erlanger Health Systems

Chattanooga, Tennessee, 37403, United States

Location

Memorial Hospital Cancer Center - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Williamson Medical Center

Franklin, Tennessee, 37068-1600, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, 37901, United States

Location

Saint Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208-3599, United States

Location

Division of Medical Oncology - Vanderbilt

Nashville, Tennessee, 37232-5536, United States

Location

AKH Vienna

Vienna (Wien), A-1090, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna (Wien), A-1090, Austria

Location

Universiteit Gent

Ghent, B-9000, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liege (Luik), 4000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Royal Victoria Hospital, Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Peterborough Oncology Clinic

Peterborough, Ontario, K9H 7B6, Canada

Location

Algoma District Medical Group

Sault Ste. Marie, Ontario, P6B 1Y5, Canada

Location

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, L2R 5K3, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Saint Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Helsinki University Central Hospital

Helsinki, FIN-0-0029, Finland

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Hopital de Neuhof

Strasbourg, 67091, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Stadisches Krankenhaus Martha Maria Halle-Dolau

Halle, 06120, Germany

Location

Allgemeines Krankenhaus

Hamburg, DOH-2-1075, Germany

Location

Lungenklinik Hemer

Hemer, D-58675, Germany

Location

Marienhospital/Ruhr University Bochum

Herne, DOH-4-4625, Germany

Location

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich (Muenchen), D-81675, Germany

Location

Oncologia Medica - Perugia

Perugia, 06122, Italy

Location

Ospedale San Filippo Neri

Rome, 00135, Italy

Location

Ospedale Carlo Forlanini

Rome, 00149, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), 20089, Italy

Location

Ospedale Civile San Giovanni e Paolo

Venezia, 30122, Italy

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, 4434-502, Portugal

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Servicio De Oncologia

Valencia, 46017, Spain

Location

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Chelsea Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  PMID: 18165640 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15541822 BACKGROUND

• 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.

  PMID: 15837997 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; N-((2S)-2-mercapto-1-oxo-4-(3,4,4- trimethyl-2,5-dioxo-1-imidazolidinyl)butyl)-L-leucyl-N,3- dimethyl-L-Valinamide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Michael Smylie, MD, MB, ChB

  Cross Cancer Institute at University of Alberta

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: July 25, 2003
• Study Start: April 4, 2000
• Primary Completion: December 10, 2003
• Study Completion: February 10, 2009
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3); ES (3); FR (7); US (18); AU (2); BE (3); DE (5); GB (2); NL (1); PL (1); CA (17); FI (1); IT (5); PT (1)