Status:
COMPLETED
Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pat...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00257426
Start Date
July 1 2005
End Date
September 1 2009
Last Update
February 14 2012
Active Locations (1)
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1
The University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599