Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	CCCWFU-0103 CCCWFU-97102, WFU-01-03, NCT00070148

Objectives

1. 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.
2. Compare the health-related quality of life of patients treated with these drugs.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Lean body mass as measured by the Bioelectrical Impedance Analysis monthly

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

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University CCOP Research Base

Edward Shaw, MD, Protocol chair		Ph: 336-713-6506; 800-446-2255 Email: eshaw@wfubmc.edu
Glenn Lesser, MD, Protocol co-chair		Ph: 336-716-9527; 800-446-2255 Email: glesser@wfubmc.edu

Registry Information
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
Trial Start Date		2004-03-31
Registered in ClinicalTrials.gov		NCT00070148
Date Submitted to PDQ		2003-08-14
Information Last Verified		2007-05-06
NCI Grant/Contract Number		CA12197

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