Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL; Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
Intervention description: On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.; After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
Intervention MeSH terms: Carboplatin; Epothilones
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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