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

April 2, 2020 updated by: NCIC Clinical Trials Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

774

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna (Wien), Austria, A-1090
        • AKH Vienna
      • Vienna (Wien), Austria, A-1090
        • Allgemeines Krankenhaus Der Stadt Wien
  • Belgium
      • Gent, Belgium, B-9000
        • Universiteit Gent
      • Liege (Luik), Belgium, 4000
        • Centre Hospitalier Régional de la Citadelle
      • Wilrijk, Belgium, 2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital, Barrie
      • Hamilton, Ontario, Canada, L8V 5C2
        • Cancer Care Ontario-Hamilton Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Peterborough, Ontario, Canada, K9H 7B6
        • Peterborough Oncology Clinic
      • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
        • Algoma District Medical Group
      • St. Catharines, Ontario, Canada, L2R 5K3
        • Hotel Dieu Health Sciences Hospital - Niagara
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M6R 1B5
        • Saint Joseph's Health Centre - Toronto
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital
      • Windsor, Ontario, Canada, N8W 2X3
        • Cancer Care Ontario - Windsor Regional Cancer Centre
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Finland
      • Helsinki, Finland, FIN-0-0029
        • Helsinki University Central Hospital
  • France
      • Besancon, France, 25030
        • CHR de Besancon - Hopital Jean Minjoz
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Grenoble, France, 38043
        • Chr De Grenoble - La Tronche
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Strasbourg, France, 67091
        • Hopital de Neuhof
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
  • Germany
      • Halle, Germany, 06120
        • Stadisches Krankenhaus Martha Maria Halle-Dolau
      • Hamburg, Germany, DOH-2-1075
        • Allgemeines Krankenhaus
      • Hemer, Germany, D-58675
        • Lungenklinik Hemer
      • Herne, Germany, DOH-4-4625
        • Marienhospital/Ruhr University Bochum
      • Munich (Muenchen), Germany, D-81675
        • Klinikum Rechts Der Isar/Technische Universitaet Muenchen
  • Italy
      • Perugia, Italy, 06122
        • Oncologia Medica - Perugia
      • Rome, Italy, 00149
        • Ospedale Carlo Forlanini
      • Rome, Italy, 00135
        • Ospedale San Filippo Neri
      • Rozzano (MI), Italy, 20089
        • Istituto Clinico Humanitas
      • Venezia, Italy, 30122
        • Ospedale Civile San Giovanni e Paolo
  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
  • Portugal
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Valencia, Spain, 46017
        • Servicio de Oncología
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonspital Aarau
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Zurich, Switzerland, CH-8091
        • UniversitaetsSpital
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Chelsea Westminster Hospital
    • England
      • London, England, United Kingdom, W6 8RF
        • Charing Cross Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
    • Georgia
      • Macon, Georgia, United States, 31201
        • Central Georgia Hematology Oncology, P.C.
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic - Burlington
    • Nebraska
      • Omaha, Nebraska, United States, 68131-2197
        • Creighton University Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73190
        • University of Oklahoma Health Sciences Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health Systems
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Hospital Cancer Center - Chattanooga
      • Franklin, Tennessee, United States, 37068-1600
        • Williamson Medical Center
      • Jackson, Tennessee, United States, 38301
        • Jackson-Madison County General Hospital
      • Knoxville, Tennessee, United States, 37901
        • Baptist Regional Cancer Center - Knoxville
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Hospital
      • Nashville, Tennessee, United States, 37208-3599
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37232-5536
        • Division of Medical Oncology - Vanderbilt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: carboplatin
Drug: paclitaxel
Experimental: BMS-275291
Drug: carboplatin
Drug: paclitaxel
Drug: rebimastat

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Investigators

  • Study Chair: Michael Smylie, MD, MB, ChB, Cross Cancer Institute at University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2000

Primary Completion (Actual)

December 10, 2003

Study Completion (Actual)

February 10, 2009

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

July 24, 2003

First Posted (Estimate)

July 25, 2003

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR18
  • CAN-NCIC-BR18 (Other Identifier: PDQ)
  • BMS-CA161-003 (Other Identifier: Bristol-Myers Squibb)
  • CDR0000068153 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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