Status:
COMPLETED
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
Lead Sponsor:
R-Pharm
Conditions:
Advanced/Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 l...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00723957
Start Date
December 1 2008
End Date
August 1 2011
Last Update
October 28 2020
Active Locations (33)
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1
Scripps Cancer Center
La Jolla, California, United States, 90237
2
Uof Md,Greenebaum Cancer Ctr.
Baltimore, Maryland, United States, 21201
3
Local Institution
Capital Federal, Buenos Aires, Argentina, 1425
4
Local Institution
Capital Federal, Buenos Aires, Argentina, 1437