AzTrials
AzTrials

Endometrial CancerPhase 2NCT00033358

Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer

A Phase 2 study testing medroxyprogesterone, ethinyl estradiol and norgestrel in people with Endometrial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 50 years, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
medroxyprogesterone, ethinyl estradiol and norgestrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Feb 2002to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • Post surgical removal of both ovaries
  • Postmenopausal women with amenorrhea greater than 12 months
  • Previous history of endometrial biopsy, hysteroscopy, dilatation and curettage, or IUD in place within the past 3 months
  • Known participation in a concurrent protocol with a pharmacological intervention
  • Recent or concurrent use of systemic steroids (i.e. prednisone) within the past four months of initiating study
  • Positive serum pregnancy test at baseline evaluation
  • Fasting triglycerides level >= 400 mg/dl
  • Cholesterol level >= 240 mg/dl
  • LDL level >= 160 mg/dl
  • HDL level =< 35 mg/dl
  • Hypertension that is currently not under good control, in the judgement of the principal investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. The primary objective is to evaluate the effect of progesterone therapy versus combination estrogen and progesterone therapy on potential surrogate endpoint biomarkers (SEBs) relevant to endometrial carcinogenesis.

II. To evaluate changes in histology and ultrasound appearance of the endometrium in women with HNPCC after 3 months of progesterone therapy versus combination estrogen and progesterone therapy compared with baseline.

III. To establish a point estimate of the baseline frequency of endometrial abnormalities looking at histological and molecular markers in a cohort of females carrying an HNPCC gene mutation.

OUTLINE: Patients are randomized to 1 of 2 arms.

All patients undergo a baseline transvaginal ultrasound and endometrial biopsy.

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

Arm II: Patients receive oral contraceptive pills (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.

Patients are followed at 6 weeks and are encouraged to return in 6 months to participate in continued endometrial screening.

Being tested
medroxyprogesterone, ethinyl estradiol, norgestrel, laboratory biomarker analysis
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • medroxyprogesteroneDrug

    Also called Depo-Provera, medroxyprogesterone acetate, MPA, Provera

    Given intramuscularly

  • ethinyl estradiolDrug

    Also called Diogyn E, EE, Estinyl, Ethinoral

    Given orally

  • norgestrelDrug

    Also called Microlut, NORGES, Ovrette, Wy-3707

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00033358
Study groupRoleWhat they receive
Arm I (medroxyprogesterone)ExperimentalPatients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90 days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.
Receives: Drug: medroxyprogesterone; Other: laboratory biomarker analysis
Arm II (ethinyl estradiol, norgestrel)ExperimentalPatients 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.
Receives: Drug: ethinyl estradiol; Drug: norgestrel; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in potential SEBs relevant to endometrial carcinogenesis.

    Measured: From baseline to completion of hormone therapy

Secondary outcomes (1)

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

    Measured: From baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2002
  3. Primary completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033358
Sponsor's protocol ID
NCI-2013-00466
Other IDs
ID01-340, CDR0000069277, NCI-P02-0218, MDA-ID-01340, N01CN05127
Status last verified
Apr 2013
First submitted
9 Apr 2002
Last updated
3 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing medroxyprogesterone, ethinyl estradiol and norgestrel in people with Endometrial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in potential SEBs relevant to endometrial carcinogenesis. (time frame: From baseline to completion of hormone therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in