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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
carboplatin
paclitaxel
rebimastat
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • University of Arkansas for Medical Sciences
  • Scripps Clinic
  • Central Georgia Hematology Oncology, P.C.
  • Queen's Medical Center
  • Carle Cancer Center
  • Lahey Clinic - Burlington
  • Creighton University Cancer Center
  • Duke University Medical Center
  • University of Oklahoma Health Sciences Center
  • Erlanger Health Systems
  • Memorial Hospital Cancer Center - Chattanooga
  • Williamson Medical Center
  • Jackson-Madison County General Hospital
  • Baptist Regional Cancer Center - Knoxville
  • Saint Thomas Hospital
  • Meharry Medical College
  • Division of Medical Oncology - Vanderbilt
  • AKH Vienna
  • Allgemeines Krankenhaus der Stadt Wien
  • Universiteit Gent
  • Centre Hospitalier Regional de la Citadelle
  • Algemeen Ziekenhuis Sint-Augustinus
  • Cross Cancer Institute
  • CancerCare Manitoba
  • Nova Scotia Cancer Centre
  • Royal Victoria Hospital, Barrie
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • Peterborough Oncology Clinic
  • Algoma District Medical Group
  • Hotel Dieu Health Sciences Hospital - Niagara
  • Toronto Sunnybrook Regional Cancer Centre
  • Mount Sinai Hospital - Toronto
  • Toronto General Hospital
  • Saint Joseph's Health Centre - Toronto
  • Humber River Regional Hospital
  • Cancer Care Ontario - Windsor Regional Cancer Centre
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre
  • Helsinki University Central Hospital
  • CHR de Besancon - Hopital Jean Minjoz
  • Hopital Avicenne
  • CHR de Grenoble - La Tronche
  • CRLCC Nantes - Atlantique
  • Hopital de Neuhof
  • Institut Claudius Regaud
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Stadisches Krankenhaus Martha Maria Halle-Dolau
  • Allgemeines Krankenhaus
  • Lungenklinik Hemer
  • Marienhospital/Ruhr University Bochum
  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen
  • Oncologia Medica - Perugia
  • Ospedale San Filippo Neri
  • Ospedale Carlo Forlanini
  • Istituto Clinico Humanitas
  • Ospedale Civile San Giovanni e Paolo
  • Academisch Ziekenhuis Maastricht
  • Medical University of Gdansk
  • Centro Hospitalar de Vila Nova de Gaia
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Marques de Valdecilla
  • Servicio De Oncologia
  • Kantonspital Aarau
  • Inselspital, Bern
  • Universitaetsspital
  • Charing Cross Hospital
  • Chelsea Westminster Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BMS-275291

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
April 2, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00006229
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 Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2000 (Actual)
Primary Completion Date
December 10, 2003 (Actual)
Study Completion Date
February 10, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
774 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-275291
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
rebimastat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Smylie, MD, MB, ChB
Organizational Affiliation
Cross Cancer Institute at University of Alberta
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Central Georgia Hematology Oncology, P.C.
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Lahey Clinic - Burlington
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Creighton University Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Erlanger Health Systems
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Memorial Hospital Cancer Center - Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Williamson Medical Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37068-1600
Country
United States
Facility Name
Jackson-Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Baptist Regional Cancer Center - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208-3599
Country
United States
Facility Name
Division of Medical Oncology - Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5536
Country
United States
Facility Name
AKH Vienna
City
Vienna (Wien)
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna (Wien)
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Universiteit Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liege (Luik)
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Royal Victoria Hospital, Barrie
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Peterborough Oncology Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 7B6
Country
Canada
Facility Name
Algoma District Medical Group
City
Sault Sainte Marie
State/Province
Ontario
ZIP/Postal Code
P6B 1Y5
Country
Canada
Facility Name
Hotel Dieu Health Sciences Hospital - Niagara
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 5K3
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Saint Joseph's Health Centre - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Cancer Care Ontario - Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FIN-0-0029
Country
Finland
Facility Name
CHR de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHR de Grenoble - La Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital de Neuhof
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Stadisches Krankenhaus Martha Maria Halle-Dolau
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Allgemeines Krankenhaus
City
Hamburg
ZIP/Postal Code
DOH-2-1075
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
D-58675
Country
Germany
Facility Name
Marienhospital/Ruhr University Bochum
City
Herne
ZIP/Postal Code
DOH-4-4625
Country
Germany
Facility Name
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
City
Munich (Muenchen)
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Oncologia Medica - Perugia
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Ospedale San Filippo Neri
City
Rome
ZIP/Postal Code
00135
Country
Italy
Facility Name
Ospedale Carlo Forlanini
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Civile San Giovanni e Paolo
City
Venezia
ZIP/Postal Code
30122
Country
Italy
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Servicio De Oncologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Universitaetsspital
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Chelsea Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
18165640
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
15541822
Citation
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.
Results Reference
background
PubMed Identifier
15837997
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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