Status:
COMPLETED
Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
Lead Sponsor:
R-Pharm
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 ce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00683904
Start Date
June 1 2008
End Date
September 1 2009
Last Update
March 10 2016
Active Locations (1)
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1
Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045