Endometrial AdenocarcinomaPhase 2NCT00064025

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

A Phase 2 study testing Laboratory Biomarker Analysis, Medroxyprogesterone and Therapeutic Conventional Surgery in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by Gynecologic Oncology Group 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

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Trial summary

This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
What is being tested?: Laboratory Biomarker Analysis, Medroxyprogesterone and Therapeutic Conventional Surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteUnited States
Study dates: Apr 2004to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus
All histologic grades and stages eligible
Diagnosis by endometrial curettage or biopsy within the past 8 weeks
Must have the initial tissue block or 16 unstained sections of 5 micron thickness available
Performance status - GOG 0-3
No history of thrombophlebitis or thromboembolic disorders

Show all 12Show fewer

No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
No concurrent aminoglutethimide
No prior cancer treatment that would preclude study therapy
No concurrent bosentan
No concurrent rifampin

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Pilot Investigation Of The Relationship Of Short Term Depo-Provera (Medroxyprogesterone Acetate) Exposure To The Morphologic , Biochemical, And Molecular Changes In Primary Endometroid Adenocarcinoma of the Uterine Corpus

Read the detailed description

PRIMARY OBJECTIVES:

Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.

II. Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.

III. Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response, steroid receptor status, immunohistochemical measures of growth and apoptosis, and gene expression profiles in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.

A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions: Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer
Being tested: Laboratory Biomarker Analysis, Medroxyprogesterone, Therapeutic Conventional Surgery

What participants receive

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

Laboratory Biomarker AnalysisOther
Correlative studies
MedroxyprogesteroneDrug
Also called Curretab
Given IM
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgical hysterectomy

Study groups in NCT00064025
Study group	Role	What they receive
Treatment (medroxyprogesterone)	Experimental	Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy. A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays. Receives: Other: Laboratory Biomarker Analysis; Drug: Medroxyprogesterone; Procedure: Therapeutic Conventional Surgery

What is being measured

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

Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data.
PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area.
Measured: During the hysterectomy, which is 21-24 days after administration of depo-provera

Secondary outcomes (2)

Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression
Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.
Measured: During the hysterectomy, which is 21-24 days after administration of depo-provera
Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression
Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.
Measured: During the hysterectomy , which is 21-24 days after administration of depo-provera

Timeline

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

Apr 2004Sep 2010

First posted9 Jul 2003 (estimated)
Study startApr 2004
Primary completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00064025
Sponsor's protocol ID: GOG-0211
Other IDs: NCI-2012-02539, CDR0000306440, GOG-0211, GOG-0211, U10CA027469
Status last verified: Mar 2016
First submitted: 8 Jul 2003
Last updated: 11 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Endometrial Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Pilot Investigation Of The Relationship Of Short Term Depo-Provera (Medroxyprogesterone Acetate) Exposure To The Morphologic , Biochemical, And Molecular Changes In Primary Endometroid Adenocarcinoma of the Uterine Corpus
ClinicalTrials.gov ID: NCT00064025
Acronym / sponsor ID: GOG-0211
Conditions: Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Gynecologic Oncology GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Apr 2004
Primary completion: Sep 2010 (actual)
First posted: 9 Jul 2003 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.

II. Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.

A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (medroxyprogesterone)	Experimental	Other: Laboratory Biomarker Analysis, Drug: Medroxyprogesterone, Procedure: Therapeutic Conventional SurgeryPatients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy. A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus
Performance status - GOG 0-3
No history of thrombophlebitis or thromboembolic disorders
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (medroxyprogesterone)
MedroxyprogesteroneAlso: CurretabGiven IM	Drug	Treatment (medroxyprogesterone)
Therapeutic Conventional SurgeryUndergo surgical hysterectomy	Procedure or surgery	Treatment (medroxyprogesterone)

Primary outcome

Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
Time frame: During the hysterectomy, which is 21-24 days after administration of depo-provera
To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data. PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area.

2 secondary outcomes

Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression
Time frame: During the hysterectomy, which is 21-24 days after administration of depo-provera
Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression
Time frame: During the hysterectomy , which is 21-24 days after administration of depo-provera

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Depo-Provera	75	68

Primary outcome: Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative

Time frame: During the hysterectomy, which is 21-24 days after administration of depo-provera. Number. Unit: percentage of participants

Measure	PR Negative (<=0.2) n = 8	PR Positive (>0.2) n = 45
Value	62.5	68.9

PR Negative (<=0.2) vs PR Positive (>0.2): p = 0.701, Fisher Exact

Population analysed: Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy and had histologic response data)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Toxicity was assessed from the time of study drug administration to the time of the hysterectomy, which occurred 21-24 days after study drug administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Depo-Provera	0 of 68 (0%)	39 of 68 (57.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 3
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Endometrial Adenocarcinoma, Metastatic Endometrial Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Zaino principal investigator

Gynecologic Oncology Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 0 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 11 Apr 2016. 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?

Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative (time frame: During the hysterectomy, which is 21-24 days after administration of depo-provera). 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 NCT00064025.

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 11 Apr 2016.