NCT00033358

Brief Summary

Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer. Hormone therapy may prevent the development of endometrial cancer in women with a genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

5.7 years

First QC Date

April 9, 2002

Last Update Submit

May 2, 2013

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in potential SEBs relevant to endometrial carcinogenesis.

    From baseline to completion of hormone therapy

Secondary Outcomes (1)

  • Changes in histology and ultrasound appearance of the endometrium in women with HNPCC

    From baseline to 3 months

Study Arms (2)

Arm I (medroxyprogesterone)

EXPERIMENTAL

Patients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90 days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

Drug: medroxyprogesteroneOther: laboratory biomarker analysis

Arm II (ethinyl estradiol, norgestrel)

EXPERIMENTAL

Patients receive OCP comprising ethinyl estradiol and norgestrel once daily on days 1-21. Treatment repeats every 28 days for 3-4 courses (3-4 packs of OCP) in the absence of unacceptable toxicity. Approximately 1 week after starting the fourth pack of OCP, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

Drug: ethinyl estradiolDrug: norgestrelOther: laboratory biomarker analysis

Interventions

medroxyprogesteroneDRUG

Given intramuscularly

Also known as: Depo-Provera, medroxyprogesterone acetate, MPA, Provera, Provera Dosepak
Arm I (medroxyprogesterone)
ethinyl estradiolDRUG

Given orally

Also known as: Diogyn E, EE, Estinyl, Ethinoral, Eticylol
Arm II (ethinyl estradiol, norgestrel)
norgestrelDRUG

Given orally

Also known as: Microlut, NORGES, Ovrette, Wy-3707
Arm II (ethinyl estradiol, norgestrel)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (medroxyprogesterone)Arm II (ethinyl estradiol, norgestrel)

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with known mutation of an HNPCC-associated gene (hMLH-1, hMSH-2, or hMSH-6) or fulfill Amsterdam Criteria and have had one or more HNPCC-associated cancers
  • No prior hysterectomy; (participants may be scheduled for prophylactic hysterectomy following the study)
  • Voluntary consent documented by a signed and witnessed informed consent
  • Negative serum pregnancy test at baseline evaluation
  • No history of pelvic irradiation for whatever cause
  • No chemotherapy for two years
  • Women \>= 40 must have had a screening mammogram within the last 12 months prior to participation in this study
  • Women who are at 50% risk of having a mutation and willing to have genetic testing

You may not qualify if:

  • Use of oral contraceptives or depoMPA or hormonal exposure, such as hormonal IUD, tamoxifen, raloxifene, or other selective estrogen receptor modulators (SERMs) within four months of initiating study; women will be asked to be off oral contraceptives or other hormonal exposure for 4 months prior to initiating study
  • Medical contraindication to use of oral contraceptives or depoMPA including:
  • Known or suspected pregnancy
  • Undiagnosed vaginal bleeding
  • Known or suspected malignancy of breast or endometrium
  • Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease
  • Gall bladder disease or liver dysfunction or disease, including hepatic adenomas or carcinoma, or abnormal liver function tests
  • Known hypersensitivity to depoMPA contraceptive injection (medroxyprogesterone acetate or any of its other ingredients)
  • Depression that is currently not under control, in the judgement of the Principal Investigator
  • History of epilepsy
  • History of diabetes
  • Coronary artery disease
  • Age \>=35 and a current tobacco smoker
  • Known inability to participate in the scheduled follow-up tests (i.e., alcohol dependence or illicit drug use)
  • Significant medical history or psychiatric problems which would make the participant a poor protocol candidate, in the opinion of the principal investigator
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

MedroxyprogesteroneMedroxyprogesterone AcetateEthinyl EstradiolNorgestrelLevonorgestrel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

HydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesNorpregnanesNorsteroidsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorpregnenes

Study Officials

  • Karen Lu

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

February 1, 2002

Primary Completion

October 1, 2007

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

US(1)