Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
Information source: Gynecologic Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer
Intervention: levonorgestrel (Drug); placebo (Other)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Gynecologic Oncology Group Official(s) and/or principal investigator(s): Gus Rodriguez, MD, Study Chair, Affiliation: NorthShore University HealthSystem Research Institute
Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
of levonorgestrel may prevent ovarian cancer.
PURPOSE: This randomized phase II trial is studying how well levonorgestrel works in
preventing ovarian cancer in patients at high risk for ovarian cancer.
Clinical Details
Official title: Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer (IND# 79,610)
Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: Percent of apoptotic epithelial cellsFrequency and severity of adverse effects by NCI CTC v.3.0
Secondary outcome: ProliferationTransforming growth factor-beta expression Safety
Detailed description:
OBJECTIVES:
Primary
- Determine the impact of levonorgestrel on the relative frequency of apoptosis in the
ovarian epithelium of patients at high risk for ovarian cancer.
Secondary
- Estimate the impact of this drug on proliferation and transforming growth factor-beta
(TGF-beta) expression in the ovarian epithelium of these patients.
- Assess the safety of this drug in these patients.
OUTLINE: This is a prospective, randomized, placebo-controlled, double-blind study. Patients
are stratified according to menopausal status (premenopausal vs postmenopausal). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral levonorgestrel once daily.
- Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for
4-6 weeks in the absence of disease progression or unacceptable toxicity, including on
the day of surgery. Patients then undergo prophylactic salpingo-oophorectomy*.
After completion of study therapy, patients are followed at 1 year.
NOTE: * Patients who are unable to have surgery completed during the expected 4-6 weeks, may
continue levonorgestrel or placebo for a time period no > 5 months. Patients unable to
undergo surgery within 5 months are removed from the study.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
DISEASE CHARACTERISTICS:
- At increased genetic risk for ovarian cancer AND planning to undergo risk-reducing
salpingo-oophorectomy (RRSO)
- Has ≥ 1 intact ovary
- Patients enrolled on clinical trial GOG-0199 and planning to undergo RRSO allowed
- Submission of fixed ovarian tissue (FN01) required
- Must meet 1 of the following additional criteria:
- Family of the patient has a documented deleterious BRCA1 or BRCA2 mutation and
either the patient herself has tested positive for a deleterious BRCA1 or BRCA2
mutation or the patient has a first- or second-degree relative with a
deleterious BRCA1 or BRCA2 mutation
- No patient with a deleterious BRCA1 or BRCA2 mutation whose first- or
second-degree relative has tested negative for the exact same mutation
- The family contains members with ≥ 2 ovarian* and/or breast cancers among the
first- or second-degree relatives (male relatives must be counted) of the
patient within the same lineage (this condition may be satisfied by multiple
primary cancers in the same person or, where breast cancer is required to meet
this criterion, ≥ 1 breast cancer must have been diagnosed prior to menopause or
at age ≤ 50 years if age at menopause is unknown)
- The patient is of Ashkenazi Jewish ethnicity (lineage via the mother) with one
first- degree or two second-degree maternal relatives with breast and/or ovarian
cancer* (where breast cancer is required to meet this criterion, ≥ 1 breast
cancer must have been diagnosed prior to menopause or at age ≤ 50 years if age
at menopause is unknown)
- The probability of carrying a BRCA1 or BRCA2 mutation, given the family pedigree
of breast and ovarian cancers, exceeds 20%, as calculated by BRCAPRO NOTE:
*Ovarian cancer in relatives includes invasive ovarian epithelial cancer,
fallopian tube cancer, and primary papillary serous carcinoma of the peritoneum;
no germ cell tumors, granulosa cell tumors, or ovarian tumors of low malignant
potential
- No prior history of ovarian cancer, including low malignant potential cancers, or
primary papillary serous carcinoma of the peritoneum
- No prior or concurrent history of breast cancer, including ductal carcinoma in situ
(DCIS) of the breast
- Women with a history of hormone receptor-negative breast cancer (both estrogen
receptor-negative and progesterone receptor-negative) are eligible
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception prior to the
prophylactic salpingo-oophorectomy
- No prior history of deep vein thrombosis, stroke, liver disease, or heart attack
- No prior history of myocardial infarction
- No known bleeding disorders or hypercoagulable states
- No other malignancy, including ductal carcinoma in situ, within 1 year of systemic
therapy, except for nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy regimen lasting ≥ 12 months
- No oral or intrauterine hormonal contraception or hormonal replacement therapy within
the past 3 months or injectable medroxyprogesterone within the past 12 months
- No intraperitoneal surgery within the past 3 months (including laparoscopy)
- No prior or concurrent radiotherapy to the pelvis
- No concurrent hormonal contraception
- No concurrent tamoxifen, raloxifene, estrogen, progesterone-like hormones, or other
hormonal medication (including hormone replacement therapy)
Locations and Contacts
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States
Evanston Hospital, Evanston, Illinois 60201-1781, United States
Gynecologic Oncology, Hinsdale, Illinois 60521, United States
Elkhart Clinic, LLC, Elkhart, Indiana 46514-2098, United States
Elkhart General Hospital, Elkhart, Indiana 46515, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana 46514, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana 46545-1470, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana 46545-1470, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana 46563, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States
Memorial Hospital of South Bend, South Bend, Indiana 46601, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana 46391, United States
St. Elizabeth Medical Center, Edgewood, Kentucky 41017, United States
Central Baptist Hospital, Lexington, Kentucky 40503-9985, United States
Borgess Medical Center, Kalamazoo, Michigan 49001, United States
Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan 49085, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan 49085, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States
Women's Cancer Center - La Canada, Las Vegas, Nevada 89169, United States
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina 28374, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio 45267, United States
Good Samaritan Hospital Cancer Treatment Center, Cincinnati, Ohio 45220, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210-1240, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States
University of Texas Medical Branch, Galveston, Texas 77555-0361, United States
University of Virginia Cancer Center, Charlottesville, Virginia 22908, United States
Carilion Gynecologic Oncology Associates, Roanoke, Virginia 24016, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2008
Last updated: September 19, 2013
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