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

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer, Islet Cell Tumor, Metastatic Cancer, Pheochromocytoma

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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

- Moderate-severe right upper quadrant pain and unintentional weight loss >

- 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


- 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 surgery, chemotherapy, or locally ablative technique for the liver cancer

- No prior radiotherapy to the upper abdomen that includes the liver in the treatment

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Tumor response

Outcome Time Frame:

at 1 year or until intervening death

Safety Issue:


Principal Investigator

Steven G. Meranze, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:

VICC GI 0365



Start Date:

December 2003

Completion Date:

October 2007

Related Keywords:

  • Head and Neck Cancer
  • Islet Cell Tumor
  • Metastatic Cancer
  • Pheochromocytoma
  • 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
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Pheochromocytoma
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell



Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838