Ovarian CancerPhase 2NCT00699907

Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer

A Phase 2 study testing flutamide in people with Ovarian Cancer, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 83 years, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: flutamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Nov 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 83 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years of age
Able to comply with study and follow-up requirements
elected to undergo prophylactic salpingo-oophorectomy
fertile patients must use effective non-hormonal contraception
agreed to use a nonhormonal means of contraception before surgery
serum bilirubin ≤ 1.0 x Upper Limit Normal (ULN), alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) ≤ 2.5 x ULN

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serum creatinine ≤ 1.5 x ULN
granulocyte count ≥ 1500/μL
platelet count ≥ 75,000/μL
hemoglobin ≥ 9 g/dL
adequate complete blood count
At high risk for developing ovarian cancer, as defined by any of the following:
Breast Cancer carried a BRCA1 or BRCA2 deleterious mutation, a Lynch syndrome mutation, and/or defined by a family history of: 1 first-degree relative with epithelial ovarian cancer, ≥1 first-degree female relative with breast cancer when ≤40 years old, ≥1 first-degree female relative with breast cancer when ≤50 years old, male relative with breast cancer, and/or family history of breast cancer or ovarian cancer.
planning to undergo oophorectomy for a medical indication
did not fulfill criteria for high risk of developing ovarian cancer

Who cannot join

liver disease, current alcohol abuse, or cirrhosis
pregnancy or lactation
current use of hormone therapy
active treatment for cancer
recent, current, or planned participation in another experimental drug study
breast cancer within the past 5 years

Show all 9Show fewer

significant traumatic injury within the past 6 months
major surgery within the past 6 months
any disease, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates the continued use of an investigational drug or that may render the patient at high risk from treatment complication

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arizona Cancer Center
Tucson, Arizona, 85724-5024

Other trials in United States

About this study

Official title: A Prospective, Phase IIA Study of the Effect of Flutamide (125 MG/DAY) Taken for 6 Weeks on Expression of Potential Biomarkers of Flutamide Action in the Ovaries of Women at Increased Risk for Ovarian Cancer

Studying samples of blood and tissue in the laboratory from patients with a high risk of developing ovarian cancer may help doctors identify and learn more about biomarkers related to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers in blood and tissue samples from patients at high risk of ovarian cancer.

Read the detailed description

OBJECTIVE: Compare the biomarkers of patients at high risk for ovarian cancer who are undergoing prophylactic oophorectomy and are interested in taking flutamide vs patients at high risk for ovarian cancer who are undergoing prophylactic oophorectomy and are not interested in taking flutamide (control) vs patients who are undergoing oophorectomy for a medical indication (control).

OUTLINE: Patients who elected not to receive flutamide received prophylactic oophorectomy or oophorectomy for a medical indication. Patients who elected to receive flutamide received 125mg once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent prophylactic oophorectomy. All patients underwent blood and ovarian tissue sample collection at the time of surgery for biomarker laboratory studies. Proteomic, microarray, and polymorphism analysis were performed on the blood and tissue samples.

Conditions: Ovarian Cancer
Being tested: flutamide
Keywords: Ovarian epithelial cancer, High risk, Biomarkers
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.

flutamideDrug
Also called Eulexin, Cytomid, Cebatrol, Chimax
Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.

Study groups in NCT00699907
Study group	Role	What they receive
Treatment Arm	Active comparator	Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy. Receives: Drug: flutamide
High Risk Arm	No intervention	High risk patients underwent risk-reducing salpingo-oophorectomy.
Low Risk Arm	No intervention	Low risk patients underwent salpingo-oophorectomy for a medical indication.

What is being measured

The primary outcome is the main question the study is designed to answer.

Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis
CSF-1 levels were measured by immunohistochemistry (IHC).
The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors.
The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei.
This applies to all measures.
Measured: Surgery
Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium
CSF-1 levels were measured by immunohistochemistry (IHC).
Measured: Surgery
Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma
CSF-1 levels were measured by immunohistochemistry (IHC).
Measured: Surgery
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis
CSF-1R levels were measured by immunohistochemistry (IHC).
Measured: Surgery
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium
CSF-1R levels were measured by immunohistochemistry (IHC).
Measured: Surgery
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma
CSF-1R levels were measured by immunohistochemistry (IHC).
Measured: Surgery
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis
ErbB4 levels were measured by immunohistochemistry (IHC).
Measured: Surgery
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium
ErbB4 levels were measured by immunohistochemistry (IHC).
Measured: Surgery
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma
ErbB4 levels were measured by immunohistochemistry (IHC).
Measured: Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Nov 2014

First posted18 Jun 2008 (estimated)
Study startJan 2005
Primary completionNov 2012
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ovarian CancerStudies 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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00699907
Sponsor's protocol ID: 04-0707-04
Other IDs: P30CA023074
Status last verified: Dec 2017
First submitted: 17 Jun 2008
Last updated: 24 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gruessner C, Gruessner A, Glaser K, AbuShahin N, Zhou Y, Laughren C, Wright H, Pinkerton S, Yi X, Stoffer J, Azodi M, Zheng W, Chambers SK. Flutamide and biomarkers in women at high risk for ovarian cancer: preclinical and clinical evidence. Cancer Prev Res (Phila). 2014 Sep;7(9):896-905. doi: 10.1158/1940-6207.CAPR-13-0408. Epub 2014 Jun 20.
PubMed 24950779

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Phase IIA Study of the Effect of Flutamide (125 MG/DAY) Taken for 6 Weeks on Expression of Potential Biomarkers of Flutamide Action in the Ovaries of Women at Increased Risk for Ovarian Cancer
ClinicalTrials.gov ID: NCT00699907
Acronym / sponsor ID: 04-0707-04
Conditions: Ovarian Cancer
Keywords: Ovarian epithelial cancer, High risk, Biomarkers
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jan 2005
Primary completion: Nov 2012 (actual)
Study completion: Nov 2014 (actual)
First posted: 18 Jun 2008 (estimated)
Results: Posted 5 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment Arm	Active comparator	Drug: flutamidePatients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
High Risk Arm	No intervention	–High risk patients underwent risk-reducing salpingo-oophorectomy.
Low Risk Arm	No intervention	–Low risk patients underwent salpingo-oophorectomy for a medical indication.

Who may qualify

Ages: 18 to 83 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

≥ 18 years of age
Able to comply with study and follow-up requirements
elected to undergo prophylactic salpingo-oophorectomy
fertile patients must use effective non-hormonal contraception
agreed to use a nonhormonal means of contraception before surgery

Key exclusion criteria (9 listed)

liver disease, current alcohol abuse, or cirrhosis
pregnancy or lactation
current use of hormone therapy
active treatment for cancer
recent, current, or planned participation in another experimental drug study

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
flutamideAlso: Eulexin, Cytomid, Cebatrol, ChimaxPatients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.	Drug	Treatment Arm

Primary outcome

Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis
Time frame: Surgery
CSF-1 levels were measured by immunohistochemistry (IHC). The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors. The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei. This applies to all measures.
Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium
Time frame: Surgery
CSF-1 levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma
Time frame: Surgery
CSF-1 levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis
Time frame: Surgery
CSF-1R levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium
Time frame: Surgery
CSF-1R levels were measured by immunohistochemistry (IHC).
Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma
Time frame: Surgery
CSF-1R levels were measured by immunohistochemistry (IHC).
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis
Time frame: Surgery
ErbB4 levels were measured by immunohistochemistry (IHC).
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium
Time frame: Surgery
ErbB4 levels were measured by immunohistochemistry (IHC).
Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma
Time frame: Surgery
ErbB4 levels were measured by immunohistochemistry (IHC).

Results and safety

Results posted to the registry on 5 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm	14	12
High Risk Arm	57	47
Low Risk Arm	56	48

Primary outcome: Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis

Time frame: Surgery. Median (Full Range). Unit: Modified H-Score

Measure	Treatment Arm n = 7	High Risk Arm n = 24	Low Risk Arm n = 15
Value	5 (0 to 210)	130 (0 to 300)	50 (5 to 270)

Treatment Arm vs High Risk Arm: p = 0.012, Wilcoxon Rank Sum Test
High Risk Arm vs Low Risk Arm: p >0.05, Wilcoxon Rank Sum Test

Population analysed: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated

Primary outcome: Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium

Time frame: Surgery. Median (Full Range). Unit: Histo-score (H-Score)

Measure	Treatment Arm n = 8	High Risk Arm n = 42	Low Risk Arm n = 39
Value	0 (0 to 30)	50 (0 to 210)	0 (0 to 120)

Treatment Arm vs High Risk Arm: p = 0.010, Wilcoxon Rank Sum Test
High Risk Arm vs Low Risk Arm: p = 0.005, Wilcoxon Rank Sum Test

Population analysed: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated

Primary outcome: Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma

Time frame: Surgery. Median (Full Range). Unit: Histo-score (H-Score)

Measure	Treatment Arm n = 11	High Risk Arm n = 45	Low Risk Arm n = 43
Value	5 (0 to 80)	40 (5 to 160)	35 (5 to 180)

Treatment Arm vs High Risk Arm: p = 0.0006, Wilcoxon Rank Sum Test
High Risk Arm vs Low Risk Arm: p >0.05, Wilcoxon Rank Sum Test

Primary outcome: Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis

Time frame: Surgery. Median (Full Range). Unit: Histo-score (H-Score)

Measure	Treatment Arm n = 6	High Risk Arm n = 21	Low Risk Arm n = 16
Value	15 (0 to 60)	160 (5 to 285)	75 (5 to 195)

Treatment Arm vs High Risk Arm: p = 0.009, Wilcoxon Rank Sum Test
High Risk Arm vs Low Risk Arm: p >0.05, Wilcoxon Rank Sum Test

Population analysed: The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	0 of 12 (0%)	9 of 12 (75%)	Not reported
High Risk Arm	0 of 47 (0%)	0 of 47 (0%)	Not reported
Low Risk Arm	0 of 48 (0%)	0 of 48 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24950779Gruessner C, Gruessner A, Glaser K, AbuShahin N, Zhou Y, Laughren C, Wright H, Pinkerton S, Yi X, Stoffer J, Azodi M, Zheng W, Chambers SK. Flutamide and biomarkers in women at high risk for ovarian cancer: preclinical and clinical evidence. Cancer Prev Res (Phila). 2014 Sep;7(9):896-905. doi: 10.1158/1940-6207.CAPR-13-0408. Epub 2014 Jun 20.
Cancer Prevention Research, 2014.Link provided by the sponsor.
American Journal of Cancer Research, 2014.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Ovarian Cancer

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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.

Setsuko K. Chambers, MD principal investigator

University of Arizona Arizona Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing flutamide in people with Ovarian Cancer, 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?

The sponsor lists 15 inclusion and 9 exclusion criteria. 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 Jul 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis (time frame: Surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00699907, which also lists 1 linked publication.

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 Jul 2018.