Official Title: “Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes”

RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes.

PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Open Label, Active Control

OBJECTIVES: - Compare the efficacy of medroxyprogesterone administered as 1 injection vs medroxyprogesterone administered as 3 injections (closed to accrual as of 1/22/03) vs venlafaxine for hot flash alleviation in women with symptomatic hot flashes. - Compare the toxic effects of these regimens in these patients. - Determine whether there is cross resistance between these 2 drugs in these patients. - Compare the 1-year efficacy of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (18 to 49 vs 50 and over), current tamoxifen use (yes vs no), current raloxifene use (yes vs no), duration of hot flash symptoms (less than 9 months vs 9 months or more), and average frequency of hot flashes per day (2-3 vs 4-9 vs 10 or more). Patients are randomized to 1 of 2 treatment arms. (Arm II closed to accrual as of 1/22/03.)

All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. - Arm I: Patients receive oral venlafaxine once daily for 6 weeks beginning on day 8.

After week 7, patients with satisfactory efficacy may continue venlafaxine for up to 6 months. Patients with unsatisfactory efficacy may cross over to arm III. - Arm II (closed to accrual as of 1/22/03): Patients receive medroxyprogesterone intramuscularly (IM) on days 8, 22, and 36 for a total of 3 injections. After week 7, patients with unsatisfactory efficacy may cross over to arm I. - Arm III: Patients receive medroxyprogesterone IM once on day 8. After week 7, patients with unsatisfactory efficacy may cross over to arm I.

Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 18 months. (Arm II closed to accrual as of 1/22/03.)

Intervention(s) in this Clinical Trial

• Drug: medroxyprogesterone
• Drug: venlafaxine

DISEASE CHARACTERISTICS:

• History of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ (currently without evidence of malignant disease) OR
• Concerns about taking estrogen for fear of breast cancer
• Bothersome hot flashes, defined as occurrence at least 14 times per week and of sufficient severity as to make patient desire therapeutic intervention
• Presence of hot flashes for at least 1 month
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• At least 6 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No prior thromboembolic disease
• No uncontrolled hypertension (persistent diastolic blood pressure greater than 95 mm
• Hg and/or systolic blood pressure greater than 160 mm Hg)

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• More than 4 weeks since prior antineoplastic chemotherapy
• No concurrent antineoplastic chemotherapy unless clinically appropriate

Endocrine therapy:

• More than 4 weeks since prior androgen or estrogen therapy
• More than 3 months since prior progesterone as part of hormone replacement therapy
• At least 1 year since any other progesterone therapy (including megestrol)
• No concurrent androgen, estrogen, or progestational agents unless clinically appropriate
• Concurrent tamoxifen, raloxifene, or aromatase inhibitors are allowed if started more than 4 weeks ago and continuation for more than 5 weeks is planned

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• More than 2 weeks since prior agents for treatment of hot flashes (e.g., clonidine, Bellergal-S, or vitamin E of more than 400 mg per day)
• More than 1 year since prior antidepressants (including Hypericum perforatum [St
• John's Wort])
• No other concurrent antidepressants or monoamine oxidase inhibitors
• No other concurrent agents for treatment of hot flashes (e.g. clonidine, Bellergal-S, or vitamin E of more than 400 mg per day)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Central Cancer Treatment Group

Overall Clinical Trial Officials and Contacts

Charles L. Loprinzi, MD Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00030914

Study ID Number: CDR0000069217

ClinicalTrials.gov Identifier: NCT00030914

Health Authority: United States: Federal Government

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