A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
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.
Checked against the public recordLast updated Oct 28, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- R-Pharm
- Interventions being studied
- Drug: Ixabepilone, 32 mg/m^2; Drug: Paclitaxel, 200 mg/m^2; Drug: Carboplatin (area under the concentration curve [AUC] 6)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Scripps Cancer CenterLa Jolla, California
- Uof Md,Greenebaum Cancer Ctr.Baltimore, Maryland
- Local InstitutionCapital Federal, Buenos Aires
- Local InstitutionCapital Federal, Buenos Aires
- Local InstitutionBuenos Aires
- Local InstitutionBankstown, New South Wales
- Local InstitutionFrankston, Victoria
- Local InstitutionNedlands, Western Australia
- Local InstitutionPoitiers
- Local InstitutionStrasbourg
- Local InstitutionStrasbourg
- Local InstitutionBad Berka
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 28, 2020. Always confirm current availability with the study team.