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A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Advanced/Metastatic Non-Small Cell Lung Cancer

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Trial Information

A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors

Outcome Description:

Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.

Outcome Time Frame:

Randomization to disease progression or death (maximum reached: 14.39 months )

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

August 2011

Related Keywords:

  • Advanced/Metastatic Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Scripps Cancer CenterLa Jolla, California  92037
Uof Md,Greenebaum Cancer Ctr.Baltimore, Maryland  21201