A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
NCT ID: NCT00723957
Last Updated: 2020-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2008-12-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
Ixabepilone, 32 mg/m^2
Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2
Carboplatin (area under the concentration curve [AUC] 6)
Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
Paclitaxel, 200 mg/m^2
IV solutions, paclitaxel, 200 mg/m\^2
Carboplatin (area under the concentration curve [AUC] 6)
Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
Interventions
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Ixabepilone, 32 mg/m^2
Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2
Paclitaxel, 200 mg/m^2
IV solutions, paclitaxel, 200 mg/m\^2
Carboplatin (area under the concentration curve [AUC] 6)
Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy
* Available paraffin-embedded tissue to measure the expression levels of βIII tubulin
* Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field
* Karnofsky performance status of 70-100
* Life expectancy of at least 3 months
* Men and women, ages 18 years and older
Exclusion Criteria
* Peripheral neuropathy greater than Grade 1
* Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
* Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
* Known HIV-positive status
* Absolute neutrophil count lower than 1500 cells mm\^3
* Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)
* Aspartate transaminase or alanine transaminase level higher than 2.5\*ULN
* Serum creatine level of 1.5 mg/dL or higher
* Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)
* Any prior antineoplastic systemic regimens.
18 Years
ALL
No
Sponsors
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R-Pharm
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Scripps Cancer Center
La Jolla, California, United States
Uof Md,Greenebaum Cancer Ctr.
Baltimore, Maryland, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Bankstown, New South Wales, Australia
Local Institution
Frankston, Victoria, Australia
Local Institution
Nedlands, Western Australia, Australia
Local Institution
Poitiers, , France
Local Institution
Strasbourg, , France
Local Institution
Strasbourg, , France
Local Institution
Bad Berka, , Germany
Local Institution
Großhansdorf, , Germany
Local Institution
Ulm, , Germany
Local Institution
Genova, , Italy
Local Institution
Milan, , Italy
Local Institution
Sondrio, , Italy
Local Institution
Terni, , Italy
Local Institution
Chelyabinsk, , Russia
Local Institution
Kazan', , Russia
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Ryazan, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Goyang-si, Gyeonggi-do, South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Baracaldo (Vizcaya), , Spain
Local Institution
Taichung, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan Hsien, , Taiwan
Countries
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References
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Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.
Related Links
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Investigator Inquiry form
Other Identifiers
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CA163-163
Identifier Type: -
Identifier Source: org_study_id