A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label study.
Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease
Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity
At least 1 site of unidimensionally measurable disease by physical exam or radiography
No known CNS metastases or leptomeningeal metastases requiring corticosteroids
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No preexisting neuropathy ≥ grade 2
No other malignancy within the past 5 years except for the following:
No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy
No infection requiring parenteral or oral anti-infective therapy
No weight loss of ≥ 10% within the past 3 months
No altered mental status or psychiatric illness that would preclude giving informed consent
No other medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other