Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer

INCLUSION CRITERIA:

• Age >18 years with no pre-existing or uncontrolled medical or psychological illnessthat would impair a patient's ability to provide informed consent or to completeprotocol therapy or quality of life questionnaires.
• A minimum of one month planned chemotherapy remaining at the time Oxandrin orMegestrol acetate is begun. Oral chemotherapy medications, biologicals, and monoclonalantibodies are included in eligibility criteria.
• Histologically confirmed solid tumor (see exceptions in ineligibility list)
• Female patients with a history of breast cancer, gynecologic cancer, and hormonallyresponsive germ cell tumors must be disease free > 5 years to be eligible for thisstudy
• Patients with non-melanoma skin cancers and carcinoma in situ of the cervix areeligible.
• History of weight loss of:

1. > 5% total body weight during the previous 6 months OR
2. > 3% in previous month OR
3. Progressive weight loss on 2 consecutive visits despite attempts at dietary,behavioral, or pharmacologic intervention.

• ECOG Performance Status of 0-2
• Life expectancy > 6 months
• Serum creatinine < 2.5mg/dl, SGOT and SGPT < 2 times upper limit of normal, totalbilirubin < 2.5 mg/dl
• Patients must be able to swallow 1 tablet twice a day or 20 cc of liquid each day
• Patients must be able to meet their nutritional requirements via the oral route withfood and/or oral supplements or via enteral tube feedings. However, Oxandrin pillsmust be administered orally.
• Patients who are taking warfarin for maintenance of central venous catheter patencyare eligible for this trial if their INR < 1.2. Because of the interaction betweenwarfarin and Oxandrin, the maintenance dose of warfarin in eligible patients should behalved to keep the INR at 1-1.2. For example, if a patient is taking 1 mg of warfarinat study entry, it is recommended that the dose be decreased to 0.5 mg per day, theirdose should be decreased to every other day, every third day, etc. to keep the INR at < 1.2. The INR must be checked weekly until stable at < 1.2.
• Patients can be receiving concurrent RT.

EXCLUSION CRITERIA:

• Ongoing or planned treatment with corticosteroid medications, estrogens, progestins (including Megestrol acetate) or any other steroid hormone during the study period.Patients who receive intermittent corticosteroids as part of a pre-chemotherapyantiemetic regimen are eligible for this study. Patients treated with Oxandrin orMegestrol acetate < 3 months before study entry are not eligible. Patients takingdronabinol or any other appetite stimulant must be off medication for a minimum of 3days prior to start of study medication.
• Patients who have had the following are ineligible:
• Prostate cancer
• Male breast cancer
• Female breast, gynecologic, or hormonally responsive germ cell tumors in the last 5years
• Primary or metastatic malignant brain tumors that have not been stable or demonstrateprogressive disease in the last 6 months.
• Leukemia, lymphoma, myeloma or other hematologic malignancies
• Men > 40 years of age should have a prostate-specific antigen (PSA) level checked ifnot monitored in the past year. Those patients with PSA > 4 ng/mL will be excludedfrom participation in the study. If required, the PSA should be done within 2 weeksprior to registration.
• Patients with hypercalcemia, nephrosis or the nephrotic phase of nephritis oruncontrolled hypertension, congestive heart failure, pulmonary edema, unstable anginaor Cushing's syndrome.
• Patients with recent (within 6 months) active thromboembolic disease or recentmyocardial infarction (within 3 months of study entry).
• Systemic anticoagulation: Patients currently on oral anticoagulants (warfarin) are noteligible unless they are taking low doses of warfarin for catheter patency. If apatient develops thromboembolic disease while on treatment, they may remain on study.It is recommended that they receive a standard loading dose of coumadin on day 1.because of the interaction between Oxandrin and Coumadin (Oxandrin elevates the INR),patients will subsequently require a much lower dose of Coumadin. The effect of thesecombined medications should develop within 24 to 48 hours. The recommended Coumadindose should be decreased to 20% of what is normally required for sufficientanticoagulation. (Example: If patient would normally receive 5 mg every day, theyshould only receive 1 mg every day.) PT/INR results should be monitored frequentlywith dosage adjustment as needed.
• Significant ascites, pleural effusions or edema which may inhibit oral food intake orinvalidate weight determinations.
• Diabetic medications are allowed, however patients taking sulfonyureas are ineligible.Below is a list of commonly used sulfonyureas (Note: This is a helpful guide, not acomplete list.): Glimepiride (Amaryl®), glyburide (DiaBeta®), chlorpropamide (Diabinese®),glipizide(Glucatrol®), combined glyburide and metformin (Glucovance®) and orinase (Tolbutamide®). There is no contraindication for concomitant use of insulin and oxandrolone (Oxandrin®) ifrequired by the patient. Any patient on insulin or other oral hypoglycemics shouldself-monitor to prevent hypo & hyperglycemia.
• Patients who are pregnant or nursing.
• Patients with history of priapism (persistant erections) and sickle cell anemia.
• Patients with a BMI(Body Mass Index) ≥ 35