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