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A Multicenter Randomized Double-Blinded Trial for Chemoprevention of Ovarian Cancer: Modulation of Biomarkers and Spectral Properties Using Contrast Enhanced Ultrasound in High-Risk Women Using Fenretinide (4-HPR)


N/A
30 Years
N/A
Not Enrolling
Female
brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer

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Trial Information

A Multicenter Randomized Double-Blinded Trial for Chemoprevention of Ovarian Cancer: Modulation of Biomarkers and Spectral Properties Using Contrast Enhanced Ultrasound in High-Risk Women Using Fenretinide (4-HPR)


OBJECTIVES:

Primary

- Compare the induction of apoptosis (as determined by TUNEL) in the ovarian epithelial
and stromal cells of participants at high risk for ovarian cancer treated with
fenretinide vs placebo.

Secondary

- Compare modulation of several intermediate markers (TGFβ, BAX, Ki-67, ER, PR, RARβ,
TGFβRI, TGFβRII, p21, p53, FAS, and FASL) in participants treated with these regimens.

- Compare early microvascular changes, using contrast-enhanced ultrasound, in
participants treated with these drugs.

- Determine whether the use of contrast agents could indicate changes in ovarian size and
architecture that may be assessed as potential surrogates for preventive effect in
these participants.

- Determine the feasibility of future chemoprevention trials for ovarian cancer.

- Determine the toxicity of fenretinide in these participants.

- Compare the microvascularity index and ovarian volume of participants treated with
these drugs.

- Correlate areas of increased microvascularity and other abnormalities with pathology
findings obtained at oophorectomy in participants treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Participants are randomized to 1 of 2 treatment arms.

- Arm I: Participants receive oral fenretinide once daily.

- Arm II: Participants receive oral placebo once daily. In both arms, treatment continues
for 6-8 weeks in the absence of unacceptable toxicity.

Within 5 days after completion of fenretinide or placebo, participants undergo bilateral
salpingo-oophorectomy.

Participants are followed at 6 weeks.

PROJECTED ACCRUAL: A total of 40 participants (20 per treatment arm) will be accrued for
this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- At high risk for developing ovarian cancer, meeting 1 of the following criteria:

- Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed
with ovarian cancer before 50 years of age

- Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed
with ovarian cancer at any age AND ≥ 1 first- or second-degree relative
diagnosed with breast or ovarian cancer at any age

- Positive BRCA1/BRCA2 test

- Planning to undergo prophylactic bilateral oophorectomy

PATIENT CHARACTERISTICS:

Age

- 30 and over

Performance status

- Zubrod 0-1

Life expectancy

- At least 12 months

Hematopoietic

- Not specified

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 1.5 times ULN

- No history of liver disease*

- No cholestatic jaundice

- No hepatic adenomas NOTE: *For patients undergoing contrast enhanced ultrasound

Renal

- BUN normal

- Creatinine normal

Cardiovascular

- No history of a congenital heart defect creating a bi-directional or right-to-left
shunt*

- No history of congestive heart failure*

- No thrombophlebitis

- No thromboembolic disease

- No cerebral vascular disease

- No coronary artery disease NOTE: *For patients undergoing contrast enhanced
ultrasound

Pulmonary

- No history of pulmonary hypertension*

- No history of pulmonary emboli*

- No history of severe emphysema* NOTE: *For patients undergoing contrast enhanced
ultrasound

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- Thyroid stimulating hormone normal

- T4 normal

- Triglycerides ≤ 1.5 times ULN

- No malignancy within the past 5 years except breast cancer or basal cell or squamous
cell skin cancer

- No evidence of recurrent disease

- No known or suspected hypersensitivity to blood, blood products, or albumin

- No undiagnosed genital bleeding

- No history of pancreatitis

- No uncontrolled diabetes

- No other severe underlying chronic disease

- No concurrent alcohol use (> 3 drinks/day or equivalent)

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 3 months since prior chemotherapy for breast cancer

Endocrine therapy

- No concurrent selective estrogen-receptor modulators, including raloxifene

- No concurrent aromatase inhibitors

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Other

- More than 3 months since prior therapeutic oral or topical vitamin A derivatives
(e.g., isotretinoin)

- No other concurrent investigational agents

- No concurrent cyclooxygenase-2 (COX-2) inhibitors

- No concurrent oral vitamin A or ascorbic acid (vitamin C) supplements > recommended
daily requirement (10,000 IU for vitamin A and 75 mg for vitamin C)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Molly A. Brewer, MD, DVM, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000396796

NCT ID:

NCT00098800

Start Date:

October 2004

Completion Date:

November 2006

Related Keywords:

  • brca1 Mutation Carrier
  • brca2 Mutation Carrier
  • Ovarian Cancer
  • ovarian epithelial cancer
  • BRCA1 mutation carrier
  • BRCA2 mutation carrier
  • Ovarian Neoplasms

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724