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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Epothilones; Paclitaxel

Criteria

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.