Clinical trial NCT00568308: Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, International, Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer
Liver Cancer
Primary Liver Cancer
Hepatocellular Carcinoma
Hepatoma
Keywords: Hepatocellular Carcinoma
PI-88
Phase III
Adjuvant Therapy
Hepatoma
Liver Cancer
Lead sponsor: Progen Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key 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

Primary outcomes:
measure: Disease-free Survival
timeFrame: End of Study
Secondary outcomes:
measure: Overall Survival
timeFrame: End of study
measure: Time to Recurrence
timeFrame: End of Study
measure: Quality of Life
timeFrame: End of Study
measure: Safety and Tolerability
timeFrame: End of Study
measure: Compliance
timeFrame: End of Study
Other outcomes:
Locations:
city: United States of America
country: United States
state: New York
city: Australia
country: Australia
city: Canada
country: Canada
city: Hong Kong
country: Hong Kong
city: Italy
country: Italy
city: Malaysia
country: Malaysia
city: Singapore
country: Singapore
city: Spain
country: Spain
city: Taiwan
country: Taiwan
city: Thailand
country: Thailand
Study officials:
affiliation: University of Hong Kong, Queen Mary Hospital
name: Ronnie TP Poon, MD
role: PRINCIPAL_INVESTIGATOR
References: