Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

774

Study ID:

NCT00006229

Recruitment Status:

Completed

Sponsor:

NCIC Clinical Trials Group

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There are 68 Locations for this study

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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Scripps Clinic
La Jolla California, 92037, United States
Central Georgia Hematology Oncology, P.C.
Macon Georgia, 31201, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Lahey Clinic - Burlington
Burlington Massachusetts, 01805, United States
Creighton University Cancer Center
Omaha Nebraska, 68131, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73190, United States
Erlanger Health Systems
Chattanooga Tennessee, 37403, United States
Memorial Hospital Cancer Center - Chattanooga
Chattanooga Tennessee, 37404, United States
Williamson Medical Center
Franklin Tennessee, 37068, United States
Jackson-Madison County General Hospital
Jackson Tennessee, 38301, United States
Baptist Regional Cancer Center - Knoxville
Knoxville Tennessee, 37901, United States
Saint Thomas Hospital
Nashville Tennessee, 37205, United States
Meharry Medical College
Nashville Tennessee, 37208, United States
Division of Medical Oncology - Vanderbilt
Nashville Tennessee, 37232, United States
AKH Vienna
Vienna (Wien) , A-109, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna (Wien) , A-109, Austria
Universiteit Gent
Gent , B-900, Belgium
Centre Hospitalier Regional de la Citadelle
Liege (Luik) , 4000, Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk , 2610, Belgium
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Nova Scotia Cancer Centre
Halifax Nova Scotia, B3H 1, Canada
Royal Victoria Hospital, Barrie
Barrie Ontario, L4M 6, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton Ontario, L8V 5, Canada
Ottawa Regional Cancer Centre
Ottawa Ontario, K1H 1, Canada
Peterborough Oncology Clinic
Peterborough Ontario, K9H 7, Canada
Algoma District Medical Group
Sault Sainte Marie Ontario, P6B 1, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines Ontario, L2R 5, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada
Mount Sinai Hospital - Toronto
Toronto Ontario, M5G 1, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada
Saint Joseph's Health Centre - Toronto
Toronto Ontario, M6R 1, Canada
Humber River Regional Hospital
Weston Ontario, M9N 1, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor Ontario, N8W 2, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Helsinki University Central Hospital
Helsinki , FIN-0, Finland
CHR de Besancon - Hopital Jean Minjoz
Besancon , 25030, France
Hopital Avicenne
Bobigny , 93009, France
CHR de Grenoble - La Tronche
Grenoble , 38043, France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain , 44805, France
Hopital de Neuhof
Strasbourg , 67091, France
Institut Claudius Regaud
Toulouse , 31052, France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours , 37044, France
Stadisches Krankenhaus Martha Maria Halle-Dolau
Halle , 06120, Germany
Allgemeines Krankenhaus
Hamburg , DOH-2, Germany
Lungenklinik Hemer
Hemer , D-586, Germany
Marienhospital/Ruhr University Bochum
Herne , DOH-4, Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich (Muenchen) , D-816, Germany
Oncologia Medica - Perugia
Perugia , 06122, Italy
Ospedale San Filippo Neri
Rome , 00135, Italy
Ospedale Carlo Forlanini
Rome , 00149, Italy
Istituto Clinico Humanitas
Rozzano (MI) , 20089, Italy
Ospedale Civile San Giovanni e Paolo
Venezia , 30122, Italy
Academisch Ziekenhuis Maastricht
Maastricht , 6202 , Netherlands
Medical University of Gdansk
Gdansk , 80-21, Poland
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia , 4434-, Portugal
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Marques de Valdecilla
Santander , 39008, Spain
Servicio De Oncologia
Valencia , 46017, Spain
Kantonspital Aarau
Aarau , 5001, Switzerland
Inselspital, Bern
Bern , CH-30, Switzerland
Universitaetsspital
Zurich , CH-80, Switzerland
Charing Cross Hospital
London England, W6 8R, United Kingdom
Chelsea Westminster Hospital
London , SW10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

774

Study ID:

NCT00006229

Recruitment Status:

Completed

Sponsor:


NCIC Clinical Trials Group

How clear is this clinincal trial information?

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