Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

NCT00257426 | Completed Phase 2

• 3 other identifiers: LCCC 0221UNC-LCCC-0221CDR0000561597
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Median survival

  6 months

Secondary Outcomes (1)

• number of subjects with toxicities

  6 months

Interventions

octreotide acetate DRUG

200mcg,3 times per day, 7 days per week, up to 36 weeks

Also known as: Sandostatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Bert H. O'Neil, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 22, 2005
• Study Start: July 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: September 1, 2009
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)