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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the anti-tumor effect of ZD0473 in patients with progressive or relapsed non-small cell lung cancer who have failed first-line platinum-based chemotherapy. II. Assess the safety and tolerability of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the efficacy of this drug, in terms of time to death, time to disease progression, disease control, and duration of response, in these patients. V. Assess the therapy outcome index, in terms of disease-related symptom relief, of these patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to time to relapse or progression after completion of first-line platinum-based chemotherapy (12 weeks or less vs more than 12 weeks). Patients receive ZD0473 IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of each course, and then every 6 weeks for 1 year after completion of study. Patients are followed at 30 days after study completion and every 6 weeks for 1 year.
PROJECTED ACCRUAL: A total of 32-73 patients (23-56 per stratum 1 and 9-17 per stratum 2) will be accrued for this study within approximately 9 months.
Primary Purpose: Treatment
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:55:50-0400
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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.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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