DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase 2

Completed

• 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.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 2000-04-06
• Study Completion: 2003-08
• Study First Submitted QC: 2004-06-07
• Study First Posted: 2004-06-08
• Status Verified: 2008-01
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Thoraxklinik Rohrbach; 🇩🇪 Heidelberg, Germany

Ospedale Bellaria; 🇮🇹 Bologna, Italy

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

Christie Hospital N.H.S. Trust; 🇬🇧 Manchester, England, United Kingdom

Oxford Radcliffe Hospital; 🇬🇧 Oxford, England, United Kingdom