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

Intervention: megestrol acetate (Drug); oxandrolone (Drug); complications of therapy assessment/management (Procedure); quality-of-life assessment (Procedure); supportive care/therapy (Procedure)

Phase: Phase 3

Enrollment status: Recruiting. Expecting to enroll 155 people.

Sponsor: Wake Forest University

Principal investigator(s) or official(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: Interventional, Supportive Care, Randomized, Active Control

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 eligible age: 18 Years. Eligible 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

Bay Area Tumor Institute, Oakland, California 94609, United States; Recruiting
Clinical Trials Office - Bay Area Tumor Institute, Phone: 510-465-8573

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States; Recruiting
Chris Roberts, CRA, Phone: 707-521-3829

Helen F. Graham Cancer Center at Christiana Care, Newark, Delaware 19713, United States; Recruiting
Stephen S. Grubbs, MD, Phone: 302-733-6227

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States; Recruiting
Janice W. Grimes, Phone: 305-674-2625

CCOP - Central Illinois, Decatur, Illinois 62526, United States; Recruiting
James L. Wade, MD, Phone: 217-876-6617, Email: jlwade3@sbcglobal.net

Kentuckiana Cancer Institute, PLLC, Louisville, Kentucky 40202, United States; Recruiting
Mary Ann Laureano, RN, CCRC, Phone: 502-561-8200, Email: mlaureano@kci.us

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70118, United States; Recruiting
Rajasekharan P. Warrier, MD, Phone: 504-896-9740

Pennington Cancer Center at Baton Rouge General, Baton Rouge, Louisiana 70806, United States; Recruiting
Clinical Trials Office - Pennington Cancer Center at Baton Rou, Phone: 225-381-6451

Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina 27216, United States; Recruiting
Geoffrey Browne, MD, Phone: 336-538-7445

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States; Recruiting
James N. Atkins, MD, Phone: 336-777-3088

High Point Regional Hospital, High Point, North Carolina 27261, United States; Recruiting
Clinical Trials Office - High Point Regional Hospital, Phone: 336-878-6107

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina 27835-6028, United States; Recruiting
Clinical Trials Office - Leo W. Jenkins Cancer Center, Phone: 252-744-2391

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States; Recruiting
Clinical Trials Office - Mission Hospitals - Memorial Campus, Phone: 828-213-4150

Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina 27403-1198, United States; Recruiting
Clinical Trials Office - Moses Cone Regional Cancer Center, Phone: 336-832-0821

Pardee Memorial Hospital, Hendersonville, North Carolina 28791, United States; Recruiting
Karen Morris, RN, Phone: 828-696-4716

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina 28233-3549, United States; Recruiting
Clinical Trials Office - Presbyterian Cancer Center, Phone: 704-384-5369

Southeastern Medical Oncology Center, Goldsboro, North Carolina 27534-9479, United States; Recruiting
James N. Atkins, MD, Phone: 919-580-0000, Email: jatkins@cancersmac.com

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States; Recruiting
Clinical Trials Office - Wake Forest University Comprehensive, Phone: 336-713-6771

CCOP - Columbus, Columbus, Ohio 43215, United States; Recruiting
Jan Dobbins, Phone: 614-488-3069

CCOP - Greenville, Greenville, South Carolina 29615, United States; Recruiting
Jeffrey K. Giguere, MD, FACP, Phone: 864-241-6251

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States; Recruiting
Clinical Trials Office - CCOP - Upstate Carolina, Phone: 800-486-5941

Danville Regional Medical Center, Danville, Virginia 24541, United States; Recruiting
Clinical Trials Office - Danville Regional Medical Center, Phone: 434-799-3753

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia 24115-4788, United States; Recruiting
James N. Atkins, MD, Phone: 276-666-7200

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

Last updated: December 4, 2006