PI-88 in Hepatocellular Carcinoma After Hepatectomy

This study has been completed.
Sponsor:
Collaborator:
Medigen Biotechnology Corporation
Information provided by:
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00247728
First received: November 1, 2005
Last updated: October 16, 2007
Last verified: October 2007
  Purpose

The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: PI-88
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study

Resource links provided by NLM:


Further study details as provided by Progen Pharmaceuticals:

Primary Outcome Measures:
  • Tumour non-recurrence rate

Secondary Outcome Measures:
  • Time to first recurrence
  • Survival rate

Estimated Enrollment: 343
Study Start Date: June 2004
Estimated Study Completion Date: June 2008
Detailed Description:

Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy.

In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed.

There are two stages to this study. In stage 1 there are three arms - untreated control and two arms are two different PI-88 dose. In stage 2 the better of the two PI-88 arms will be continued against the control arm.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients have voluntarily given written informed consent
  • Age ≥ 18 years but ≤ 75 years
  • Males or females
  • Histological diagnosis of hepatocellular carcinoma
  • Curative hepatectomy within the past 4-6 weeks
  • ECOG performance status of 0 to 2
  • Cardiac functional capacity ≤ to class II (New York Heart Association)
  • Patients with adequate renal, hepatic, and haematopoietic function as defined by:

    • Serum creatinine ≤ 2.0 mg/dL
    • Total bilirubin < 2.5 mg/dL
    • Neutrophil count > 1.5 x 10^9/L
    • ALT < 5 x upper limit of normal (ULN)
    • White blood cell (WBC) count ≥ 3 x 10^9/L
    • Platelet count ≥ 80 x 10^9/L
    • Prothrombin time international normalized ratio (PT-INR) ≤ 1.3 (or PT-INR ≤ 1.4 but PT within normal range)
    • Activated partial thromboplastin time (APTT) < ULN

Exclusion Criteria:

  • Patients with history of allergy and/or hypersensitivity to anticoagulants/thrombolytic agents, especially heparin.
  • Patients with history of immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or other platelet disease
  • Patients with previous positive result in a heparin-induced thrombocytopenia (HIT) antibody test.
  • Patients with any tumour metastasis.
  • Patients with uncontrolled infection or serious infection within the past 4 weeks.
  • Patients with myocardial infarction, stroke, or congestive heart failure within the past 3 months.
  • Patients with history of inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
  • Patients with acute or chronic gastrointestinal bleeding within the past 1 year.
  • Patients with a history of drug abuse or psychiatric disorder.
  • Patients with known HIV infection or AIDS-related illness.
  • Patients who received other investigational or anti-neoplastic medication within the past 4 weeks.
  • Use of aspirin, aspirin-containing medications, non-steroidal anti-inflammatory drugs (except for COX-2 inhibitors), heparin, low molecular weight heparin, warfarin, anti-platelet drugs, or any other anticoagulant medications 2 weeks prior to or during the study period.
  • Women who are pregnant or breast-feeding.
  • Women of child-bearing potential who are not using an adequate method of contraception.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247728

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813-46
Chang Gung Memorial Hospital-Linkou Medical Centre
Kwei-Shan, Taiwan, 333
Taichung Veterans General Hospital
Taichung, Taiwan, 407
China Medical University Hospital
Taichung, Taiwan, 404
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
Progen Pharmaceuticals
Medigen Biotechnology Corporation
Investigators
Principal Investigator: Pei-Jer Chen, MD, PhD National Taiwan University Hospital
  More Information

No publications provided by Progen Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00247728     History of Changes
Other Study ID Numbers: MG 002, PR88204
Study First Received: November 1, 2005
Last Updated: October 16, 2007
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by Progen Pharmaceuticals:
PI-88
post resection hepatoma
adjuvant therapy
hepatectomy
hepatoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 28, 2014