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Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes


Phase 3
18 Years
N/A
Not Enrolling
Female
Hot Flashes

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Trial Information

Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes


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.)

Inclusion 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

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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069217

NCT ID:

NCT00030914

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Hot Flashes
  • hot flashes
  • Hot Flashes

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
CCOP - OklahomaTulsa, Oklahoma  74136
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Medcenter One Health SystemBismarck, North Dakota  58501
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259