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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00257426 |
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 |
MedlinePlus related topics: | Cancer Liver Cancer |
ChemIDplus related topics: | Octreotide Octreotide acetate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma |
Estimated Enrollment: | 48 |
Study Start Date: | July 2005 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |||||
The University of North Carolina Lineberger Comprehensive Cancer Center | |||||
Chapel Hill, North Carolina, United States, 27599 |
UNC Lineberger Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Bert H. O'Neil, MD | UNC Lineberger Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000561597, UNC-LCCC-0221 |
First Received: | November 18, 2005 |
Last Updated: | August 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00257426 |
Health Authority: | United States: Institutional Review Board |
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