Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
This study has been completed.
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00257426
First received: November 18, 2005
Last updated: February 12, 2012
Last verified: February 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment 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:
Further study details as provided by UNC Lineberger Comprehensive Cancer Center:
Primary Outcome Measures:
- Median survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- number of subjects with toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
| Enrollment: | 31 |
| Study Start Date: | July 2005 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: octreotide acetate
200mcg,3 times per day, 7 days per week, up to 36 weeks
Other Name: Sandostatin
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
Investigators
| Principal Investigator: | Bert H. O'Neil, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00257426 History of Changes |
| Other Study ID Numbers: | LCCC 0221, UNC-LCCC-0221, CDR0000561597 |
| Study First Received: | November 18, 2005 |
| Last Updated: | February 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
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 May 16, 2013