Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors

NCT00466856 | Terminated Phase 2 DMC

• 2 other identifiers: VICC GI 0365VU-VICC-GI-0365
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.

Conditions

Head and Neck Cancer; Islet Cell Tumor; Metastatic Cancer; Pheochromocytoma

Keywords

neoplastic syndrome; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; thyroid gland medullary carcinoma; metastatic pheochromocytoma; recurrent islet cell carcinoma; liver metastases; recurrent pheochromocytoma; gastrinoma; insulinoma; WDHA syndrome; glucagonoma; pancreatic polypeptide tumor; somatostatinoma

Outcome Measures

Primary Outcomes (1)

• Tumor response

  at 1 year or until intervening death

Secondary Outcomes (3)

• Toxicity as measured by CTC v3.0

  at 1 year or until intervening death

• Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary

  at 1 year or until intervening death

• Patient report of Health-related quality of life (HRQOL)

  at 1 year or until intervening death

Study Arms (1)

Sir-Spheres

EXPERIMENTAL

Drug: octreotide acetate; Radiation: yttrium Y 90 resin microspheres

Interventions

octreotide acetate DRUG

Lung/liver Ratio Dose of SIR-Spheres * \<10% Administer full dose of SIR-Spheres * 10% to 15% Reduce dose of SIR-Spheres by 20% * 16% to 20% Reduce dose of SIR-Spheres by 40% * \>20% Do not give SIR-Spheres

Also known as: octreotide

Sir-Spheres

yttrium Y 90 resin microspheres RADIATION

radiation

Also known as: octreotide

Sir-Spheres

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Pathologically confirmed neuroendocrine tumor metastatic to the liver * Well-differentiated or moderately well-differentiated neuroendocrine tumors * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan * Symptomatic disease, meeting one of the following criteria: * Refractory carcinoid symptoms, defined as Carcinoid Symptom Severity scale \> 2 despite use of octreotide acetate at ≥ 200 mcg subcutaneously three times daily (or 20 mg intramuscularly once monthly) for ≥ 4 weeks * Evidence of radiographic progression with either of the following manifestations: * Moderate-severe right upper quadrant pain and unintentional weight loss \> 10% * Decline in Karnofsky performance status \> 10 points * At least a 20% increase in the sum of the longest diameters of target lesions in the liver within the past 12 months * No more than 75% replacement of normal liver by neuroendocrine tumor * No more than 20% arteriovenous lung shunting on a technetium Tc 99m macro-aggregated albumin nuclear scan * No equivocal, nonmeasurable, or nonevaluable liver metastasis PATIENT CHARACTERISTICS: * Karnofsky performance status 50-100% * Life expectancy ≥ 6 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Creatinine ≤ 1.5 mg/dL * Bilirubin ≤ 2.0 mg/dL * Albumin ≥ 3.0 g/dL * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 65,000/mm³ * Hemoglobin \> 9.0 g/dL * INR ≤ 1.4 * No hepatic arterial anatomy that would preclude the administration of study treatment into the liver * No nonmalignant disease that would preclude study participation * No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix PRIOR CONCURRENT THERAPY: * Prior surgery, chemotherapy, or locally ablative technique for the liver cancer allowed * No prior radiotherapy to the upper abdomen that includes the liver in the treatment field * No investigational drug or agent/procedure (i.e., participation in another clinical trial) within the past 4 weeks * No other specific anticancer treatment (other than octreotide acetate) during and for 3 months after completion of study therapy

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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Adenoma, Islet Cell; Neoplasm Metastasis; Pheochromocytoma; Neoplasms; Carcinoma, Medullary; Carcinoma, Islet Cell; Gastrinoma; Insulinoma; Vipoma; Glucagonoma; Somatostatinoma

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

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

Study Officials

• Steven G. Meranze, MD

  Vanderbilt-Ingram 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: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: December 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2007
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

US (1)