Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma

Phase 3

Terminated

• Conditions: Cancer; Liver Cancer; Primary Liver Cancer; Hepatocellular Carcinoma; Hepatoma
• Interventions: Drug: placebo; Drug: PI-88

• Registration Number: NCT00568308
• Lead Sponsor: Progen Pharmaceuticals

Brief Summary

The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Detailed Description

Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-06
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4 - 6 weeks prior to randomisation.
• ECOG performance status 0 to 2
• Child Pugh classification A or B

Key

Exclusion Criteria

• Any evidence of tumour metastasis or co-existing malignant disease
• Any prior recurrence of HCC or any liver resection prior to the most recent procedure
• History of prior HCC therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
2	PI-88	-

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	End of Study

Secondary Outcome Measures

Name	Time	Method
Overall Survival	End of study
Time to Recurrence	End of Study
Quality of Life	End of Study
Safety and Tolerability	End of Study
Compliance	End of Study