Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00257426
First received: November 18, 2005
Last updated: February 12, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Drug: octreotide acetate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Median survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of subjects with toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0


Enrollment: 31
Study Start Date: July 2005
Study Completion Date: September 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: octreotide acetate
    200mcg,3 times per day, 7 days per week, up to 36 weeks
    Other Name: Sandostatin
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00257426

Locations
United States, North Carolina
The University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Bert H. O'Neil, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00257426     History of Changes
Other Study ID Numbers: LCCC 0221, UNC-LCCC-0221, CDR0000561597
Study First Received: November 18, 2005
Last Updated: February 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014