brca1 Mutation CarrierNCT00098800
Fenretinide in Preventing Ovarian Cancer in Participants Who Are at High Risk for Developing Ovarian Cancer and Planning to Undergo Surgery to Remove the Ovaries
A study testing fenretinide in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fenretinide may prevent ovarian cancer. PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer
- What is being tested?
- fenretinide
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Nov 2006
- Phase
- Interventional
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
Official title: 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)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fenretinide may prevent ovarian cancer.
PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing ovarian cancer and planning to undergo surgery to remove the ovaries.
Read the detailed description
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.
- Being tested
- fenretinide
- Keywords
- ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenretinideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2004 (estimated)
- Study startOct 2004
- Primary completionAug 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for brca1 Mutation CarrierStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Molly A. Brewer, MD, DVM, MS, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098800
- Sponsor's protocol ID
- CDR0000396796
- Other IDs
- P30CA016672, UARIZ-GYN-01021, UARIZ-HSC-02190, MDA-GYN-01021
- Status last verified
- Nov 2006
- First submitted
- 8 Dec 2004
- Last updated
- 24 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00098800
- Acronym / sponsor ID
- CDR0000396796
- Keywords
- ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 9 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fenretinide may prevent ovarian cancer.
PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing ovarian cancer and planning to undergo surgery to remove the ovaries.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenretinide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Molly A. Brewer, MD, DVM, MS principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fenretinide in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by University of Arizona at 1 site 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?
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 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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.
Where can I read the original study information?
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 24 Mar 2010.