Palliative Care Study in Patients With Advanced Cancer

Inclusion Criteria:

* · Histologically confirmed malignancy (excluding central nervous
* system malignancy)
* · Not a candidate for, or refuses, curative anti-neoplastic therapy.
* · Between the ages of 18 and 80.
* · Symptoms of advanced cancer (loss of appetite, fatigue, weakness,
* malaise) that are not attributed to anemia, concomitant illnesses, or
* obstruction or loss of organ function.
* · Karnofsky performance status of ³40%, \_\<\_ 80%.
* · Normal cognition, interpreted as a Mini-Mental State Score of at
* least 20.
* · Life expectancy of \>4 months.
* · Decrease in weight of at least 5% over the preceding 6 months, with
* no weight gain over the most recent 30 days
* · Pretreatment laboratory data within 7 days of enrollment (if
* screening labs are done within 3 days of Day 1, they need not be
* repeated on Day 1).
* ¨ Hemoglobin \>8.5 g/dL on no, or on stable doses (hematocrit stable
* within 1 gram and dose stable for one month) of Epogen or similar
* medication.
* ¨ Absolute neutrophil count (ANC) ³1,500/mm\^3 .
* ¨ Platelets ³50,000/mm\^3 .
* ¨ Total bilirubin £1.5 the upper limit of normal (ULN).
* ¨ ALT and AST £2.5 times the ULN, or, if the patient has liver
* metastases, £5 times the ULN.
* ¨ Creatinine £1.5 mg/dL.
* ¨ Fasting blood sugar -\<1.2 x ULN
* ¨ Normal T3, T4, TSH
* · Voluntary written informed consent before performance of any
* study-related procedure that is not part of normal medical care.
* · Ability to self-administer subcutaneous medication, or to have an
* assistant who can administer the study medication according to the
* protocol.
* · Female patient is post-menopausal, surgically sterilized, or willing
* to use acceptable methods of birth control (i.e., a hormonal
* contraceptive, intra-uterine device, diaphragm with spermicide, or
* condom with spermicide, or abstinence) for the duration of the study.
* · Male patient agrees to use an acceptable barrier method for
* contraception during the study.
* · If on an antidepressant, the dose must have been stabilized for at
* least 60 days

Exclusion Criteria:

* · Received immunotherapy, radiation therapy or experimental therapy
* within three weeks.
* · Receiving chemotherapy other than third-line, single agent therapy;
* permitted third-line, single agent dose must be stable for at least
* one month.
* · Diabetes requiring insulin or oral hypoglycemic agents.
* · Mechanical reason to be unable to eat, or is reasonably expected to
* develop an obstruction during the next eight weeks
* · Myocardial infarction within six months of enrollment.
* · Uncontrolled brain metastases or central nervous system disease.
* · Major surgery within four weeks of enrollment.
* · Severe allergies to milk or milk products.