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Trial NCT00699907

Resource URI: http://static.linkedct.org/resource/trials/NCT00699907
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/34731>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/35283>
linkedct:brief_title Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5381>
linkedct:condition <http://static.linkedct.org/resource/condition/9444>
linkedct:criteria DISEASE CHARACTERISTICS: - At high risk for developing ovarian cancer, as defined by any of the following: - Known inherited BRCA-1 or -2 mutation - Recognized familial breast/ovarian or ovarian cancer syndrome - Has at least one first-degree relative with ovarian cancer - Has a family history of breast cancer meeting 1 of the following criteria: - More than one relative with breast cancer AND < 50 years of age - Relative(s) with male breast cancer - One relative with breast cancer AND < 40 years of age - Meets 1 of the following criteria: - Planning to undergo prophylactic oophorectomy AND is willing to receive flutamide - Planning to undergo prophylactic oophorectomy AND is not willing to receive flutamide (control) - Planning to undergo oophorectomy for a medical indication (control) - No breast cancer within the past 5 years PATIENT CHARACTERISTICS: - Granulocyte count  1,500/µL - Platelet count  75,000/µL - Hemoglobin  9 g/dL - Serum bilirubin normal - AST and ALT  2.5 times upper limit of normal (ULN) - Alkaline phosphatase  2.5 times ULN - Serum creatinine  1.5 times ULN - Not pregnant or nursing - Fertile patients must use effective non-hormonal contraception - Able to comply with study and follow-up requirements - No liver disease, including cirrhosis or viral or other hepatitis - No current alcohol abuse - No significant traumatic injury within the past 6 months - No disease, metabolic dysfunction, 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 PRIOR CONCURRENT THERAPY: - More than 6 months since prior major surgery - No other concurrent hormonal therapy - No concurrent participation in another experimental drug study
linkedct:description OBJECTIVES: - Identify biomarkers of flutamide action in ovarian epithelial cells after 6 weeks of treatment with flutamide in patients at high risk for ovarian cancer. - Examine the effect of 2 dose levels of flutamide in these patients. - Assess whether there is a dose response in relation to biomarker expression in these patients. - Compare the results of this pilot study in 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 elect not to receive flutamide undergo prophylactic oophorectomy or oophorectomy for a medical indication. Patients who elect to receive flutamide are randomized to 1 of 2 arms. - Arm I: Patients receive oral flutamide once daily for 6 weeks in the absence of unacceptable toxicity. Patients then undergo prophylactic oophorectomy. - Arm II: Patients receive oral flutamide once daily (at a higher dose than in arm I) for 6 weeks in the absence of unacceptable toxicity. Patients then undergo prophylactic oophorectomy. All patients undergo blood and ovarian tissue sample collection at the time of surgery for biomarker laboratory studies. Proteomic, microarray, and polymorphism analysis are performed on the blood and tissue samples.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 140 (xsd:int)
linkedct:firstreceived_date June 17, 2008
linkedct:id NCT00699907
linkedct:intervention <http://static.linkedct.org/resource/intervention/38847>
rdfs:label Trial NCT00699907
linkedct:lastchanged_date February 3, 2009
linkedct:lead_sponsor_agency University of Arizona
linkedct:location <http://static.linkedct.org/resource/location/208727>
linkedct:nct_id NCT00699907
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A PROSPECTIVE, PHASE IIA STUDY OF THE EFFECT OF FLUTAMIDE (125 OR 250 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
linkedct:org_study_id CDR0000597520
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53709>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/3038>
foaf:page <http://clinicaltrials.gov/show/NCT00699907>
linkedct:phase Phase 2
linkedct:primary_completion_date November 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/10380>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/5276>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7170>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7551>
linkedct:secondary_id UARIZ-04-0707-01
linkedct:secondary_id UARIZ-HSC04184
linkedct:secondary_id UARIZ-SRC17834
linkedct:source National Cancer Institute (NCI)
linkedct:start_date January 2005
linkedct:study_design Prevention, Randomized, Open Label, Active Control
linkedct:study_type Interventional
linkedct:summary RATIONALE: 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. It may also help doctors learn more about the effects of flutamide on biomarkers. PURPOSE: This randomized phase II trial is studying the effect of flutamide on biomarkers in blood and tissue samples from patients at high risk of ovarian cancer.
rdf:type linkedct:trials
linkedct:verification_date January 2009