Trial record 1 of 1 for:    NCT00445887
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Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00445887
First received: March 7, 2007
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: levonorgestrel
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Percent of apoptotic epithelial cells [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects by NCI CTC v.3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proliferation [ Designated as safety issue: No ]
  • Transforming growth factor-beta expression [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral levonorgestrel once daily.
Drug: levonorgestrel
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo once daily.
Other: placebo
Given orally

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445887

  Show 37 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Gus Rodriguez, MD NorthShore University HealthSystem Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00445887     History of Changes
Other Study ID Numbers: GOG-0214, NCI-2009-00588
Study First Received: March 7, 2007
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gynecologic Oncology Group:
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on April 23, 2014