Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00445887|
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : January 11, 2018
Last Update Posted : November 19, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Carcinoma||Other: Laboratory Biomarker Analysis Drug: Levonorgestrel Other: Placebo||Phase 2|
I. Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer.
I. Estimate the impact of this drug on proliferation and transforming growth factor-beta (TGF-beta) expression in the ovarian epithelium of these patients.
II. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer|
|Actual Study Start Date :||March 10, 2008|
|Actual Primary Completion Date :||December 11, 2013|
Experimental: Arm I (levonorgestrel)
Patients receive oral levonorgestrel once daily.
Other: Laboratory Biomarker Analysis
Placebo Comparator: Arm II (placebo)
Patients receive oral placebo once daily.
Other: Laboratory Biomarker Analysis
- Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue [ Time Frame: Surgical specimen (4 - 6 weeks after entry) ]The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.
- Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 [ Time Frame: Up to 20 weeks ]Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.
- Proportion of Proliferation as Measured by Ki-67 [ Time Frame: Time of surgery (4 to 6 weeks after entry) ]
- Patients With High Expression of Transforming Growth Factor-beta 1 [ Time Frame: Baseline to time of surgery (4 to 6 weeks) ]
- Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue [ Time Frame: Surgical specimen (4-6 weeks after entry) ]The median proportion of cells that are considered to be apoptotic are counted in the fallopian tube tissue sample, among the total number of cells available in the sample slide
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|Ages Eligible for Study:||30 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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
- No concurrent tamoxifen, raloxifene, estrogen, progesterone-like hormones, or other hormonal medication (including hormone replacement therapy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445887
|Principal Investigator:||Gustavo C Rodriguez||Gynecologic Oncology Group|
|Responsible Party:||Gynecologic Oncology Group|
|Other Study ID Numbers:||
NCI-2009-00588 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0214 ( Other Identifier: Gynecologic Oncology Group )
GOG-0214 ( Other Identifier: DCP )
GOG-0214 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
|First Posted:||March 9, 2007 Key Record Dates|
|Results First Posted:||January 11, 2018|
|Last Update Posted:||November 19, 2019|
|Last Verified:||November 2019|
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Endocrine System Diseases
Contraceptive Agents, Hormonal
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Hormonal