Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Ovarian Carcinoma

In brief

This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.

Key facts

Study ID

NCT00445887

Run by

Gynecologic Oncology Group

People needed

60

Starts

2008-03-10

Last updated by the study team

2019-11-19

Who can join

Age: 30 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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
• 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
• 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

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• University of California San Diego — San Diego, California, United States
• Colorado Gynecologic Oncology Group — Aurora, Colorado, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Hinsdale Hematology Oncology Associates Incorporated — Hinsdale, Illinois, United States
• Sudarshan K Sharma MD Limited-Gynecologic Oncology — Hinsdale, Illinois, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Michiana Hematology Oncology PC-Elkhart — Elkhart, Indiana, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• IU Health La Porte Hospital — La Porte, Indiana, United States
• Michiana Hematology Oncology PC-Mishawaka — Mishawaka, Indiana, United States
• Saint Joseph Regional Medical Center-Mishawaka — Mishawaka, Indiana, United States
• Michiana Hematology Oncology PC-Plymouth — Plymouth, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Michiana Hematology Oncology PC-South Bend — South Bend, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Michiana Hematology Oncology PC-Westville — Westville, Indiana, United States
• Saint Elizabeth Medical Center South — Edgewood, Kentucky, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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