CompletedPhase 2NCT00723957

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

StatusCompleted
PhasePhase 2
U.S. locations33
SponsorR-Pharm
01
Study overview

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)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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