Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer

R-Pharm

Status and phase: Completed; Phase 1

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL; Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683904

CA163-160

Details and patient eligibility

About

The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥20 years
• Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)
• Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent
• No prior chemotherapy-containing regimens for the treatment of NSCLC
• Eastern Cooperative Oncology Group performance status of 0-1
• Life expectancy of at least 12 weeks
• Accessible for treatment and follow up; patients who could be hospitalized for first 15 days of Cycle 1
• Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy)

Exclusion criteria

• Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug
• Women pregnant or breast feeding
• Women with a positive pregnancy test result on enrollment or prior to study drug administration
• Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP
• Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases
• Prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine)
• Common Terminology Criteria (CTC) Grade 2 or greater neuropathy
• Psychiatric or other disorders rendering the patient incapable of complying with protocol requirements
• Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (Patients with a history of malignancy but without evidence of disease for 5 years are eligible)
• Serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy.
• Myocardial infarction, unstable angina, or unstable congestive heart failure within 6 months
• Known history of infection with human immunodeficiency virus
• Inadequate bone marrow function
• Inadequate hepatic function
• Inadequate renal function
• Known prior severe hypersensitivity reaction (CTC Grade 2 or greater) to agents containing Cremophor®EL
• Known severe hypersensitivity reaction to agents containing carboplatin and other platinum
• Prior treatment with an epothilone and/or with platinum
• History of high-dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years
• On treatment with strong Cytochrome P450 3A4 inhibitor
• Current imprisonment
• Compulsorily detention for treatment of psychiatric or physical illness

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL

Active Comparator group

Treatment:

Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL

Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL

Active Comparator group

Treatment:

Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL