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

Head and Neck Cancer Clinical Trial

Official title:

Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00466856
• Other study ID #: VICC GI 0365
• Secondary ID: VU-VICC-GI-0365
• Status: Terminated
• Phase: Phase 2
• First received: April 25, 2007
• Last updated: May 17, 2012
• Start date: December 2003
• Est. completion date: October 2007

Study information

• Verified date: May 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with progressive liver metastases from neuroendocrine tumors.

Secondary

• Determine the toxicity of this treatment in these patients.

• Determine the symptomatic relief of patients treated with this regimen.

• Determine the health-related quality of life of patients receiving this treatment.

OUTLINE: Patients have an catheter placed into the hepatic artery percutaneously through the groin and then undergo selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) via the catheter on day 1. Patients also receive octreotide acetate IV 1 hour prior to, during, and 2 hours after Sir-Spheres® injection. Patients may undergo above treatment in another lobe of the liver (if each lobe is treated separately) 4 weeks later.

Patients undergo functional performance, health-related quality of life, and symptom severity assessment prior to initial treatment and after completion of study treatment.

After completion of study treatment, patients are followed periodically for at least 1 year.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Head and Neck Cancer
• Head and Neck Neoplasms
• Islet Cell Tumor
• Metastatic Cancer
• Neoplasm Metastasis
• Neuroendocrine Tumors
• Pheochromocytoma

Intervention

Drug:
• octreotide acetate
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

Radiation:
• yttrium Y 90 resin microspheres
radiation

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response		at 1 year or until intervening death	No
Secondary	Toxicity as measured by CTC v3.0		at 1 year or until intervening death	Yes
Secondary	Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary	The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.	at 1 year or until intervening death	No
Secondary	Patient report of Health-related quality of life (HRQOL)	HRQOL will be determined via the Medical Outcome Study 36-item short form, which includeds 8 individual scales, physical and mental component summary scores and is normed to both health and clinical populations.	at 1 year or until intervening death	No