Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00257426|
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : February 14, 2012
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 or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: octreotide acetate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||September 2009|
- Drug: octreotide acetate
200mcg,3 times per day, 7 days per week, up to 36 weeksOther Name: Sandostatin
- Median survival [ Time Frame: 6 months ]
- number of subjects with toxicities [ Time Frame: 6 months ]Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257426
|United States, North Carolina|
|The University of North Carolina Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Bert H. O'Neil, MD||UNC Lineberger Comprehensive Cancer Center|