RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.

PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.

Condition	Treatment or Intervention	Phase
Quality of Life weight changes unspecified adult solid tumor, protocol specific	Drug: megestrol  Drug: oxandrolone  Procedure: complications of therapy assessment/management  Procedure: quality-of-life assessment  Procedure: supportive care/therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol.
• Compare the health-related quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-III vs IV), concurrent radiotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral oxandrolone twice daily.
• Arm II: Patients receive oral megestrol once daily. In both arms, treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity.

Quality of life, weight, and body composition are assessed at baseline, at 1, 2, and 3 months during study therapy, and then at 1 month after study completion.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 62-155 patients (31-77 per treatment arm) will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor, excluding any of the following:
• Breast cancer
• Ovarian cancer
• Prostate cancer
• Hormonally responsive germ cell tumors
• Primary or metastatic malignant brain tumors
• Leukemia
• Lymphoma
• Myeloma
• Other hematologic malignancies
• Currently receiving chemotherapy
• Weight loss meeting criteria for 1 of the following:
• At least 5% total body weight loss within the past 6 months
• At least 3% weight loss within the past month
• Progressive weight loss on 2 consecutive visits despite dietary, behavioral, or pharmacologic intervention
• Body Mass Index no greater than 35
• No significant ascites, pleural effusion, or edema that would preclude oral food intake or invalidate weight determinations

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• SGOT and SGPT no greater than 2 times upper limit of normal
• Bilirubin no greater than 2.5 mg/dL

Renal

• Creatinine no greater than 2.5 mg/dL
• No hypercalcemia
• No nephrosis or nephrotic phase of nephritis

Cardiovascular

• No uncontrolled hypertension
• No congestive heart failure
• No unstable angina
• No myocardial infarction within the past 3 months
• No active thromboembolic disease within the past 6 months

Pulmonary

• No pulmonary edema

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other pre-existing or uncontrolled medical condition that would preclude study participation or giving informed consent
• No psychological illness that would preclude study participation or giving informed consent
• No Cushing's syndrome
• No uncontrolled diabetes (i.e., HbA1C greater than 10%)
• Prostate-specific antigen no greater than 4 ng/mL (men age 40 and over)
• Able to swallow 8 small tablets or 20 cc of liquid daily
• Able to meet nutritional requirements orally (with food or supplements) or enteral tube feedings

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• More than 3 months since prior oxandrolone or megestrol
• No concurrent corticosteroids
• Concurrent intermittent corticosteroids as part of a pre-chemotherapy antiemetic regimen are allowed
• No concurrent estrogens
• No other concurrent progestins (including megestrol)
• No other concurrent steroid hormone

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent oral anticoagulants (e.g., warfarin) for systemic anticoagulation
• Concurrent warfarin for maintenance of central venous catheter patency allowed provided INR is no greater than 1.2
• No concurrent oral hypoglycemic agents

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1030,  United States; Recruiting
      Southeastern Medical Oncology Center, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting

Study chairs or principal investigators

Edward G. Shaw, MD,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   
Glenn J. Lesser, MD,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000330073; CCCWFU-0103; CCCWFU-97102; NCT00070148
Record last reviewed:  July 2004
Last Updated:  March 21, 2005
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070148
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08