DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00005091
- Lead Sponsor
- Daiichi Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Ospedale Bellaria
🇮🇹Bologna, Italy
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Academisch Ziekenhuis der Vrije Universiteit
🇳🇱Amsterdam, Netherlands
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Thoraxklinik Rohrbach
🇩🇪Heidelberg, Germany
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom