Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatments levonorgestrel, placebo
Phase phase 2
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date March 2008
End date December 2013
Trial size 60 participants
Trial identifier NCT00445887, GOG-0214, NCI-2009-00588

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking double-blind
Primary purpose prevention
Arm
(Experimental)
Patients receive oral levonorgestrel once daily.
levonorgestrel
Given orally
(Placebo Comparator)
Patients receive oral placebo once daily.
placebo
Given orally

Primary Outcomes

Measure
Percent of apoptotic epithelial cells
time frame:
Frequency and severity of adverse effects by NCI CTC v.3.0
time frame:

Secondary Outcomes

Measure
Proliferation
time frame:
Transforming growth factor-beta expression
time frame:
Safety
time frame:

Eligibility Criteria

Female participants at least 30 years old.

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)

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.