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

Study 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 lung cancer and beta III (βIII)-tubulin-positive tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIxabepilone, 32 mg/m^2 and Paclitaxel, 200 mg/m^2

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 28, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?33 U.S. locations

Locations may change over time.

Who runs it?R-Pharm

Study sponsor

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)

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

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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