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.