Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257426
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2005-11-18
Brief Title:
Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer
Detailed Description:
OBJECTIVES
Primary
To verify that long-acting somatostatin analog octreotide Sandostatin LAR depot will extend median survival from 5 months to 875 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
Primary
To verify that long-acting somatostatin analog octreotide Sandostatin LAR depot will extend median survival from 5 months to 875 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000561597 | OTHER | PDQ number | None |
| UNC-LCCC-0221 | None | None | None |