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