T900607 in Treating Patients With Unresectable Liver Cancer

Phase 2

Completed

• Conditions: Liver Cancer

• Registration Number: NCT00054262
• Lead Sponsor: University Hospitals Seidman Cancer Center

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 T900607 in treating patients who have unresectable liver cancer.

Detailed Description

OBJECTIVES:

* Determine the complete and partial response rates of patients with chemotherapy-naïve unresectable hepatocellular carcinoma treated with T900607.

* Determine the efficacy of this drug, in terms of duration of response and time to disease progression, in these patients.

* Determine the pharmacokinetics of this drug in these patients.

* Determine the safety profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive T900607 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Primary Completion: 2004-03
• Status Verified: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

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 (1)

Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States