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Lung CancerPhase 2/3NCT00006229

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

A Phase 2/3 study testing carboplatin, paclitaxel and rebimastat in people with Lung Cancer, run by NCIC Clinical Trials Group at 69 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, paclitaxel and rebimastat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
774 participants
Where
69 sitesin 14 countries
Study dates
4 Apr 2000to 10 Feb 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

69 sites in 14 countries.

69 sites in 14 countries

United States18 sites

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Lahey Clinic - Burlington

    Burlington, Massachusetts, 01805

  • Erlanger Health Systems

    Chattanooga, Tennessee, 37403

  • Memorial Hospital Cancer Center - Chattanooga

    Chattanooga, Tennessee, 37404

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Williamson Medical Center

    Franklin, Tennessee, 37068-1600

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • Scripps Clinic

    La Jolla, California, 92037

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Central Georgia Hematology Oncology, P.C.

    Macon, Georgia, 31201

  • Saint Thomas Hospital

    Nashville, Tennessee, 37205

  • Meharry Medical College

    Nashville, Tennessee, 37208-3599

  • Division of Medical Oncology - Vanderbilt

    Nashville, Tennessee, 37232-5536

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73190

  • Creighton University Cancer Center

    Omaha, Nebraska, 68131-2197

  • Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

Canada17 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Medical Group

    Sault Ste. Marie, Ontario, P6B 1Y5

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Saint Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France7 sites

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Avicenne

    Bobigny, 93009

  • CHR de Grenoble - La Tronche

    Grenoble, 38043

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Hopital de Neuhof

    Strasbourg, 67091

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

Other trials in France

Germany5 sites

  • Stadisches Krankenhaus Martha Maria Halle-Dolau

    Halle, 06120

  • Allgemeines Krankenhaus

    Hamburg, DOH-2-1075

  • Lungenklinik Hemer

    Hemer, D-58675

  • Marienhospital/Ruhr University Bochum

    Herne, DOH-4-4625

  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen

    Munich (Muenchen), D-81675

Other trials in Germany

Italy5 sites

  • Oncologia Medica - Perugia

    Perugia, 06122

  • Ospedale San Filippo Neri

    Rome, 00135

  • Ospedale Carlo Forlanini

    Rome, 00149

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Ospedale Civile San Giovanni e Paolo

    Venezia, 30122

Other trials in Italy

Belgium3 sites

  • Universiteit Gent

    Ghent, B-9000

  • Centre Hospitalier Regional de la Citadelle

    Liege (Luik), 4000

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Spain3 sites

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Servicio De Oncologia

    Valencia, 46017

Other trials in Spain

Switzerland3 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Inselspital, Bern

    Bern, CH-3010

  • Universitaetsspital

    Zurich, CH-8091

Other trials in Switzerland

Austria2 sites

  • AKH Vienna

    Vienna (Wien), A-1090

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna (Wien), A-1090

Other trials in Austria

United Kingdom2 sites

  • Charing Cross Hospital

    London, England, W6 8RF

  • Chelsea Westminster Hospital

    London, SW10 9NH

Other trials in United Kingdom

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, FIN-0-0029

Other trials in Finland

Netherlands1 site

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

Other trials in Netherlands

Poland1 site

  • Medical University of Gdansk

    Gdansk, 80-211

Other trials in Poland

Portugal1 site

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
carboplatin, paclitaxel, rebimastat
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00006229
Study groupRoleWhat they receive
BMS-275291ExperimentalNot described
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: rebimastat
PlaceboPlacebo comparatorNot described
Receives: Drug: carboplatin; Drug: paclitaxel

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2003 (estimated)
  2. Study start4 Apr 2000
  3. Primary completion10 Dec 2003
  4. Study completion10 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
774 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006229
Sponsor's protocol ID
BR18
Other IDs
CAN-NCIC-BR18, BMS-CA161-003, CDR0000068153
Status last verified
Apr 2020
First submitted
11 Sep 2000
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18165640

  • 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 LK, Cheung MC, Ding K, Hasan B, Seymour L, Le Maitre A, Leighl NB, Shepherd FA. Venous thromboembolism and nonsmall cell lung cancer: a pooled analysis of National Cancer Institute of Canada Clinical Trials Group trials. Cancer. 2009 Dec 1;115(23):5516-25. doi: 10.1002/cncr.24596.

    PubMed 19711465

  • 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.

    PubMed 15541822

  • 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.

    PubMed 15837997

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing carboplatin, paclitaxel and rebimastat in people with Lung Cancer, run by NCIC Clinical Trials Group at 69 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Canada, France, Germany, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006229, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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