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Trial record 60 of 483 for:    colon cancer | ( Map: Texas, United States )

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

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ClinicalTrials.gov Identifier: NCT00033358
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 9, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE February 2002
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
Change in potential SEBs relevant to endometrial carcinogenesis. [ Time Frame: From baseline to completion of hormone therapy ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00033358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
Changes in histology and ultrasound appearance of the endometrium in women with HNPCC [ Time Frame: From baseline to 3 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
Official Title  ICMJE Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC
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.
Detailed Description

PRIMARY OBJECTIVES:

I. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Endometrial Cancer
Intervention  ICMJE
  • Drug: medroxyprogesterone
    Given intramuscularly
    Other Names:
    • Depo-Provera
    • medroxyprogesterone acetate
    • MPA
    • Provera
    • Provera Dosepak
  • Drug: ethinyl estradiol
    Given orally
    Other Names:
    • Diogyn E
    • EE
    • Estinyl
    • Ethinoral
    • Eticylol
  • Drug: norgestrel
    Given orally
    Other Names:
    • Microlut
    • NORGES
    • Ovrette
    • Wy-3707
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE
  • Experimental: Arm I (medroxyprogesterone)
    Patients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90 days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.
    Interventions:
    • Drug: medroxyprogesterone
    • Other: laboratory biomarker analysis
  • Experimental: Arm II (ethinyl estradiol, norgestrel)
    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.
    Interventions:
    • Drug: ethinyl estradiol
    • Drug: norgestrel
    • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2010)
52
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00033358
Other Study ID Numbers  ICMJE NCI-2013-00466
ID01-340
CDR0000069277
NCI-P02-0218
MDA-ID-01340
N01CN05127 ( Other Grant/Funding Number: US NIH Grant/Contract Award Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen Lu M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP