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

Alternate Title

Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Completed 18 and over NCI NCCTG-N99C7 NCI-P02-0204, NCT00030914

Objectives

1. 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.
2. Compare the toxic effects of these regimens in these patients.
3. Determine whether there is cross resistance between these 2 drugs in these patients.
4. Compare the 1-year efficacy of these regimens in these patients.

Entry Criteria

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

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)

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

Expected Enrollment

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.)

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.

Loprinzi CL, Levitt R, Barton D, et al.: Phase III comparison of depomedroxyprogesterone acetate to venlafaxine for managing hot flashes: North Central Cancer Treatment Group Trial N99C7. J Clin Oncol 24 (9): 1409-14, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-284-2511 Email: cloprinzi@mayo.edu

Registry Information
Official Title		Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes
Trial Start Date		2002-04-19
Registered in ClinicalTrials.gov		NCT00030914
Date Submitted to PDQ		2002-01-09
Information Last Verified		2004-08-27
NCI Grant/Contract Number		CA31946

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