Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2008 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on November 18, 2005. Last Updated on August 30, 2008 History of Changes

Sponsor:	UNC Lineberger Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00257426

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 II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Median survival [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	July 2005

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Bert H. O'Neil, MD

UNC Lineberger Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00257426 History of Changes
Other Study ID Numbers:	CDR0000561597, UNC-LCCC-0221
Study First Received:	November 18, 2005
Last Updated:	August 30, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by National Cancer Institute (NCI):

adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:

Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012