Liver CancerPhase 2NCT00257426
Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
A Phase 2 study testing octreotide acetate in people with Liver Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- octreotide acetate
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Official title: A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
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.
Read the detailed description
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.
- Conditions
- Liver Cancer
- Being tested
- octreotide acetate
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octreotide acetateDrug
Also called Sandostatin
200mcg,3 times per day, 7 days per week, up to 36 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Median survival
Measured: 6 months
Secondary outcomes (1)
number of subjects with toxicities
Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bert H. O'Neil, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257426
- Sponsor's protocol ID
- LCCC 0221
- Other IDs
- UNC-LCCC-0221, CDR0000561597
- Status last verified
- Feb 2012
- First submitted
- 18 Nov 2005
- Last updated
- 14 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00257426
- Acronym / sponsor ID
- LCCC 0221
- Conditions
- Liver Cancer
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| octreotide acetateAlso: Sandostatin200mcg,3 times per day, 7 days per week, up to 36 weeks | Drug | – |
Primary outcome
Median survival
Time frame: 6 months
1 secondary outcome
number of subjects with toxicities
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert H. O'Neil, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing octreotide acetate in people with Liver Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.