Clinical trial NCT00466856 (phase 2, status: terminated)
Conditions: head and neck cancer, islet cell tumor, metastatic cancer, pheochromocytoma
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: octreotide acetate
SMILES: [H][C@]1(NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CSSC[C@H](NC1=O)C(=O)N[C@H](CO)[C@@H](C)O)NC(=O)[C@H](N)CC1=CC=CC=C1)[C@@H](C)O
Reason stopped: 
    due to slow accrual
  
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