DX-8951f in Treating Patients With Liver Cancer

Phase 2

Completed

• Conditions: Liver Cancer

• Registration Number: NCT00004108
• Lead Sponsor: Daiichi Sankyo

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 liver cancer.

Detailed Description

OBJECTIVES: I. Evaluate the antitumor activity of DX-8951f in terms of antitumor response, response duration, and survival in patients with hepatocellular carcinoma. II. Assess the quantitative and qualitative toxicities of this treatment regimen in this patient population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.

OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for at least 2 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 over 12 months.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2004-04-15
• Study First Posted: 2004-04-16
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States

Cancer Therapy & Research Center; 🇺🇸 San Antonio, Texas, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States