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

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.

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.

Eligibility Criteria:
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