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Unspecified Adult Solid Tumor, Protocol SpecificPhase 3NCT00070148

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

A Phase 3 study testing Megestrol Acetate and Oxandrolone 20 mg in people with Unspecified Adult Solid Tumor, Protocol Specific and Weight Changes, run by Wake Forest University Health Sciences at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Megestrol Acetate and Oxandrolone 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
20 sitesUnited States
Study dates
1 Mar 2004to 1 Aug 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • > 5% total body weight during the previous 6 months OR
  • > 3% in previous month OR
  • 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.

Who cannot join

  • Ongoing or planned treatment with corticosteroid medications, estrogens, progestins (including Megestrol acetate) or any other steroid hormone during the study period. Patients who receive intermittent corticosteroids as part of a pre-chemotherapy antiemetic regimen are eligible for this study. Patients treated with Oxandrin or Megestrol acetate < 3 months before study entry are not eligible. Patients taking dronabinol or any other appetite stimulant must be off medication for a minimum of 3 days prior to start of study medication.
  • Patients who have had the following are ineligible:
  • Prostate cancer
  • Male breast cancer
  • Female breast, gynecologic, or hormonally responsive germ cell tumors in the last 5 years
  • Primary or metastatic malignant brain tumors that have not been stable or demonstrate progressive disease in the last 6 months.
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  • Leukemia, lymphoma, myeloma or other hematologic malignancies
  • Men > 40 years of age should have a prostate-specific antigen (PSA) level checked if not monitored in the past year. Those patients with PSA > 4 ng/mL will be excluded from participation in the study. If required, the PSA should be done within 2 weeks prior to registration.
  • Patients with hypercalcemia, nephrosis or the nephrotic phase of nephritis or uncontrolled hypertension, congestive heart failure, pulmonary edema, unstable angina or Cushing's syndrome.
  • Patients with recent (within 6 months) active thromboembolic disease or recent myocardial infarction (within 3 months of study entry).
  • Systemic anticoagulation: Patients currently on oral anticoagulants (warfarin) are not eligible unless they are taking low doses of warfarin for catheter patency. If a patient develops thromboembolic disease while on treatment, they may remain on study. It is recommended that they receive a standard loading dose of coumadin on day 1. because of the interaction between Oxandrin and Coumadin (Oxandrin elevates the INR), patients will subsequently require a much lower dose of Coumadin. The effect of these combined medications should develop within 24 to 48 hours. The recommended Coumadin dose should be decreased to 20% of what is normally required for sufficient anticoagulation. (Example: If patient would normally receive 5 mg every day, they should only receive 1 mg every day.) PT/INR results should be monitored frequently with dosage adjustment as needed.
  • Significant ascites, pleural effusions or edema which may inhibit oral food intake or invalidate weight determinations.
  • Diabetic medications are allowed, however patients taking sulfonyureas are ineligible. Below is a list of commonly used sulfonyureas (Note: This is a helpful guide, not a complete list.):
  • Glimepiride (Amaryl®), glyburide (DiaBeta®), chlorpropamide (Diabinese®), glipizide(Glucatrol®), combined glyburide and metformin (Glucovance®) and orinase (Tolbutamide®).
  • There is no contraindication for concomitant use of insulin and oxandrolone (Oxandrin®) if required by the patient. Any patient on insulin or other oral hypoglycemics should self-monitor to prevent hypo \& hyperglycemia.
  • Patients who are pregnant or nursing.
  • Patients with history of priapism (persistant erections) and sickle cell anemia.
  • Patients with a BMI(Body Mass Index) ≥ 35

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Pennington Cancer Center at Baton Rouge General

    Baton Rouge, Louisiana, 70806

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • Southeastern Medical Oncology Center - Goldsboro

    Goldsboro, North Carolina, 27534

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Kentuckiana Cancer Institute, PLLC

    Louisville, Kentucky, 40202

  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115-4788

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70118

  • Helen F. Graham Cancer Center at Christiana Care

    Newark, Delaware, 19713

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Megestrol Acetate, Oxandrolone 20 mg
Keywords
weight changes, unspecified adult solid tumor, protocol specific
Medical subject headings
Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Megestrol AcetateDrug

    Megace by mouth for 12 weeks

  • Oxandrolone 20 mgDrug

    Also called Oxandrolone, Oxandrin

    20 mg/day for 3 months (12 weeks)

Study groups in NCT00070148
Study groupRoleWhat they receive
Arm 1 Oxandrolone 20 mg dailyActive comparatorOxandrolone 20 mg (10 mg BID) for 12 weeks. 4 additional weeks of follow-up.
Receives: Drug: Oxandrolone 20 mg
Megace 800 mgActive comparatorMegestrol acetate 800 mg daily for 12 weeks. 4 additional weeks of follow-up.
Receives: Drug: Megestrol Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lean body mass as measured by the Bioelectrical Impedance Analysis monthly

    Measured: 1 month intervals

Secondary outcomes (5)

  1. Weight

    Measured: 1 month intervals

  2. Body fat as measured by the Bioelectrical Impedance Analysis monthly

    Measured: one month intervals

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

    Measured: one month intervals

  4. Performance status as measured by ECOG criteria

    Measured: one month intervals

  5. Toxicity as measured by standard NCI toxicity criteria

    Measured: one month interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2003 (estimated)
  2. Study start1 Mar 2004
  3. Primary completion1 Aug 2007
  4. Study completion1 Aug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070148
Sponsor's protocol ID
IRB00011294
Other IDs
U10CA081851, REBACCCWFU97102
Status last verified
Sep 2021
First submitted
3 Oct 2003
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Megestrol Acetate and Oxandrolone 20 mg in people with Unspecified Adult Solid Tumor, Protocol Specific and Weight Changes, run by Wake Forest University Health Sciences at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean body mass as measured by the Bioelectrical Impedance Analysis monthly (time frame: 1 month intervals). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00070148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.

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