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 illness that would impair a patient's ability to provide informed consent or to complete protocol therapy or quality of life questionnaires.
• •A minimum of one month planned chemotherapy remaining at the time Oxandrin or Megestrol acetate is begun. Oral chemotherapy medications, biologicals, and monoclonal antibodies 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 hormonally responsive germ cell tumors must be disease free \> 5 years to be eligible for this study
• •Patients with non-melanoma skin cancers and carcinoma in situ of the cervix are eligible.
• •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, total bilirubin \< 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 with food and/or oral supplements or via enteral tube feedings. However, Oxandrin pills must be administered orally.
• •Patients who are taking warfarin for maintenance of central venous catheter patency are eligible for this trial if their INR \< 1.2. Because of the interaction between warfarin and Oxandrin, the maintenance dose of warfarin in eligible patients should be halved to keep the INR at 1-1.2. For example, if a patient is taking 1 mg of warfarin at study entry, it is recommended that the dose be decreased to 0.5 mg per day, their dose 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.