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PURPOSE: This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer.
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
The University of North Carolina Lineberger Comprehensive Cancer Center
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:26:18-0400
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Determine the 6-month progression free survival (PFS) rate associated with IMC-A12 in combination with depot octreotide acetate (octreotide) in patients with metastatic neuroendocrine tumo...
Octreotide is a somatostatin analogue and has been used off-label for a variety of conditions. There are no specific guidelines for the use of octreotide in neonates and its safety and efficacy have n...
Gastroenteropancreatic neuroendocrine tumors (NETs) are a relatively rare group of heterogeneous neoplasms. The most significant advance in therapy of NETs has been the advent of the somatostatin anal...
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Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.
Tumors or cancer of the LIVER.
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 126.96.36.199.
A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...