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

Condition(s) targeted: Quality of Life; Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes

Intervention: megestrol acetate (Drug); oxandrolone (Drug); quality-of-life assessment (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Wake Forest University

Official(s) and/or principal investigator(s):
Edward G. Shaw, MD, Study Chair, Affiliation: Wake Forest University
Glenn J. Lesser, MD, Affiliation: Wake Forest University

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.

Official title: A Phase III Randomized Study Comparing The Effects Of Oxandrolone (Oxandrin) And Megestrol Acetate (Megace) On Lean Body Mass, Weight, Body Fat, And Quality Of Life In Patients With Solid Tumors And Weight Loss Receiving Chemotherapy

Study design: Supportive Care, Randomized, Active Control

Primary outcome: Lean body mass as measured by the Bioelectrical Impedance Analysis monthly

Secondary outcome:

Weight

Body fat as measured by the Bioelectrical Impedance Analysis monthly

Health-related quality of life as measured by the Functional Assessment of Cancer Therapy with subscales for anorexia/cachexia and fatigue

Performance status as measured by ECOG criteria

Toxicity as measured by standard NCI toxicity criteria

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor, excluding any of the following:

- Breast cancer

- Female breast cancer allowed if disease free ≥ 5 years

- Ovarian cancer

- Prostate cancer

- Gynecologic or hormonally responsive germ cell tumors within the past 5 years

- Primary or metastatic malignant brain tumors unless they have been stable or

demonstrate no evidence of disease within the past 6 months

- 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

- No concurrent sulfonyureas (e. g., glimepiride, glyburide, chlorpropamide, glipizide,

combined glyburide and metformin, and orinase)

Radiotherapy

- Concurrent radiotherapy allowed

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

Helen F. Graham Cancer Center at Christiana Care, Newark, Delaware 19713, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Kentuckiana Cancer Institute, PLLC, Louisville, Kentucky 40202, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70118, United States

Pennington Cancer Center at Baton Rouge General, Baton Rouge, Louisiana 70806, United States

Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina 27216, United States

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States

High Point Regional Hospital, High Point, North Carolina 27261, United States

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina 27835-6028, United States

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States

Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina 27403-1198, United States

Pardee Memorial Hospital, Hendersonville, North Carolina 28791, United States

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina 28233-3549, United States

Southeastern Medical Oncology Center - Goldsboro, Goldsboro, North Carolina 27534, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Danville Regional Medical Center, Danville, Virginia 24541, United States

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia 24115-4788, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2004
Last updated: May 23, 2008