Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Liver Cancer Clinical Trial

Official title:

A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257426
• Other study ID #: LCCC 0221
• Secondary ID: UNC-LCCC-0221CDR
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2005
• Last updated: February 12, 2012
• Start date: July 2005
• Est. completion date: September 2009

Study information

• Verified date: February 2012
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective treatment for liver cancer.

PURPOSE: This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer.

Description:

OBJECTIVES:

Primary

• To verify that long-acting somatostatin analog octreotide (Sandostatin LAR) depot will extend median survival from 5 months to 8.75 months in patients with locally advanced or metastatic hepatocellular carcinoma with a CLIP score of 3 or more.

Secondary

• To document tolerability of this drug in this patient population.

OUTLINE: Patients are stratified according to underlying degree of liver disease as defined by CLIP score classification.

Patients receive short-acting octreotide subcutaneously three times daily on days 1-21 OR days 1-28. If the patient tolerates short-acting octreotide, the first dose of long-acting octreotide (Sandostatin LAR) depot will be given intramuscularly beginning on day 8 OR day

15. Treatment with long-acting octreotide repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed monthly for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Newly diagnosed or recurrent hepatocellular carcinoma (HCC) as defined by tissue biopsy OR alpha fetoprotein (AFP) > 1,000 ng/mL with compatible mass on CT scan or MRI

• Recurrence of previously resected HCC will not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator

• Locally advanced OR metastatic disease

• Unmeasurable disease allowed if initial diagnosis was made according to the above criteria and/or recurrence has been confirmed by tissue biopsy or radiological imaging

• CLIP score = 3

• Not a candidate for surgical resection or liver transplant

• Not a candidate for loco-regional therapy (e.g., ablation, embolization, hepatic arterial infusion therapy), but could have received such therapy in the past

• No fibrolamellar HCC

• No clinically apparent central nervous system metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

• Life expectancy = 8 weeks

• Karnofsky performance status 60-100%

• Hemoglobin = 8.5 g/dL

• Platelet count = 50,000/mm³

• Total bilirubin = 5.0 mg/dL

• AST or ALT = 5 times upper limit of normal (ULN)

• Creatinine = 2 times ULN

• PT = 28

• INR = 2.5

• No active variceal bleeding within the past 3 months

• No encephalopathy grade 3-4

• No ongoing ethanol or intravenous drug abuse

• Not pregnant or breast feeding

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Any number of prior therapies (e.g., chemotherapy, resection, embolization, or radiofrequency/ethanol ablation therapy) allowed

• No concurrent chemotherapy, radiotherapy, or immunotherapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• octreotide acetate
200mcg,3 times per day, 7 days per week, up to 36 weeks

Locations

Country	Name	City	State
United States	The University of North Carolina Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median survival		6 months	No
Secondary	number of subjects with toxicities	Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0	6 months	Yes