A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer

Completed · Phase 2

Conditions studied: Advanced/Metastatic Non-Small Cell Lung Cancer

In brief

The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

Key facts

Study ID

NCT00723957

Run by

R-Pharm

People needed

260

Starts

2008-12-01

Expected to finish

2011-08-01

Last updated by the study team

2020-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)
• 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

You may not qualify if…

• Uncontrolled brain metastases
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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