Chemotherapy in Treating Patients With Liver Cancer

Phase 2

• Conditions: Liver Cancer

• Registration Number: NCT00003044
• Lead Sponsor: Matrix Pharmaceutical

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery.

Detailed Description

OBJECTIVES: I. Evaluate the safety and efficacy of cisplatin-epinephrine injectable gel (Intradose MPI-5010) in patients with unresectable primary hepatocellular carcinoma.

OUTLINE: This is an open label, two stage, multicenter study. Patients receive intratumoral treatment with ciplatin-epinephrine (MPI-5010) once weekly, for up to four treatments within a six week period, followed by an evaluation two weeks after last treatment. Immediately after the first course, an optional second course of treatment may be undertaken at the discretion of the investigator. Patients with a complete response, partial response, and/or an increase in necrosis of at least 30% of total treated tumor volume will be followed monthly for up to 6 months. At the completion of 6 months follow up or following documentation of disease progression or development of new tumors, patients are monitored for survival in an extended follow up period. All nonresponders at the last 2 week posttreatment evaluation are entered in the extended follow up and monitored monthly for survival.

PROJECTED ACCRUAL: Up to 55 patients will be accrued for this study.

Study Timeline

• Study Start: 1996-09
• Study First Submitted: 1999-11-01
• Status Verified: 2000-04
• Study First Submitted QC: 2004-08-11
• Study First Posted: 2004-08-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Johns Hopkins Oncology Center; 🇺🇸 Baltimore, Maryland, United States

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong