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.
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.
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
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There are 68 Locations for this study
Birmingham Alabama, 35294, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92037, United States
Macon Georgia, 31201, United States
Honolulu Hawaii, 96813, United States
Urbana Illinois, 61801, United States
Burlington Massachusetts, 01805, United States
Omaha Nebraska, 68131, United States
Durham North Carolina, 27710, United States
Oklahoma City Oklahoma, 73190, United States
Chattanooga Tennessee, 37403, United States
Chattanooga Tennessee, 37404, United States
Franklin Tennessee, 37068, United States
Jackson Tennessee, 38301, United States
Knoxville Tennessee, 37901, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37208, United States
Nashville Tennessee, 37232, United States
Vienna (Wien) , A-109, Austria
Vienna (Wien) , A-109, Austria
Gent , B-900, Belgium
Liege (Luik) , 4000, Belgium
Wilrijk , 2610, Belgium
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Halifax Nova Scotia, B3H 1, Canada
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 1, Canada
Peterborough Ontario, K9H 7, Canada
Sault Sainte Marie Ontario, P6B 1, Canada
St. Catharines Ontario, L2R 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M6R 1, Canada
Weston Ontario, M9N 1, Canada
Windsor Ontario, N8W 2, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Helsinki , FIN-0, Finland
Besancon , 25030, France
Bobigny , 93009, France
Grenoble , 38043, France
Nantes-Saint Herblain , 44805, France
Strasbourg , 67091, France
Toulouse , 31052, France
Tours , 37044, France
Halle , 06120, Germany
Hamburg , DOH-2, Germany
Hemer , D-586, Germany
Herne , DOH-4, Germany
Munich (Muenchen) , D-816, Germany
Perugia , 06122, Italy
Rome , 00135, Italy
Rome , 00149, Italy
Rozzano (MI) , 20089, Italy
Venezia , 30122, Italy
Maastricht , 6202 , Netherlands
Gdansk , 80-21, Poland
Vila Nova de Gaia , 4434-, Portugal
Madrid , 28041, Spain
Santander , 39008, Spain
Valencia , 46017, Spain
Aarau , 5001, Switzerland
Bern , CH-30, Switzerland
Zurich , CH-80, Switzerland
London England, W6 8R, United Kingdom
London , SW10 , United Kingdom
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