RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in previously untreated patients with stage IIIB or IV non-small cell lung cancer. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Assess the time to progression and survival status of these patients. OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Helsinki University Central Hospital
Helsinki, Finland
Thoraxklinik Rohrbach
Heidelberg, Germany
Ospedale Bellaria
Bologna, Italy
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, Netherlands
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Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom