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RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.
- Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival time and 12-month survival rate of patients treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1.
Patients are followed for survival every 3 months after discontinuing study treatment.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.
Masking: Open Label, Primary Purpose: Treatment
Medical Oncology and Hematology, P.C.
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:12-0400
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectivene...
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Tumors or cancer of the LUNG.
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.
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A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).
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