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

R-Pharm

Status and phase: Completed; Phase 2

Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer

Treatments: Drug: Ixabepilone, 32 mg/m^2; Drug: Carboplatin (area under the concentration curve [AUC] 6); Drug: Paclitaxel, 200 mg/m^2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00723957

CA163-163

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)

Experimental group

Treatment:

Drug: Ixabepilone, 32 mg/m^2

Drug: Carboplatin (area under the concentration curve [AUC] 6)

Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)

Active Comparator group

Treatment:

Drug: Paclitaxel, 200 mg/m^2

Drug: Carboplatin (area under the concentration curve [AUC] 6)