Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00683904
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00683904
Study Brief:
Protocol Section:
NCT00683904