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

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Octreotide

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