Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

Study Type	Interventional
Study Design	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
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; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer
Interventions	Other: Laboratory Biomarker Analysis; Drug: Medroxyprogesterone; Procedure: Therapeutic Conventional Surgery
Enrollment	75

Participant Flow

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Recruitment Details	The study was activated on 4/12/2004 and closed to accrual on 9/2/2008.
Pre-assignment Details

Arm/Group Title	Depo-Provera
Arm/Group Description	Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Period Title: Overall Study
Started	75
Completed	68
Not Completed	7
Reason Not Completed
Ineligible	4
Inevaluable	3

Baseline Characteristics

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Arm/Group Title		Depo-Provera
Arm/Group Description		Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Overall Number of Baseline Participants		68
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	68 participants
30-39 years		1
40-49 years		3
50-59 years		28
60-69 years		30
70-79 years		3
80-89 years		3
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	68 participants
	Female	68 100.0%
	Male	0 0.0%

Outcome Measures

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1. Primary Outcome

Title	Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
Description	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.
Time Frame	During the hysterectomy, which is 21-24 days after administration of depo-provera

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PR Negative (<=0.2)	PR Positive (>0.2)
Arm/Group Description:	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	8	45
Measure Type: Number; Unit of Measure: percentage of participants
	62.5	68.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PR Negative (<=0.2), PR Positive (>0.2)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.701
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression
Description	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.
Time Frame	During the hysterectomy, which is 21-24 days after administration of depo-provera

Outcome Measure Data

Analysis Population Description

Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)

Arm/Group Title	Depo-Provera
Arm/Group Description:	Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Overall Number of Participants Analyzed	53
Mean (Standard Error); Unit of Measure: Aggregate Score from Immunohistochemistr
	-0.77 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Depo-Provera
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	[Not Specified]
	Method	Paired t-test
	Comments	[Not Specified]

3. Secondary Outcome

Title	Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression
Description	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.
Time Frame	During the hysterectomy , which is 21-24 days after administration of depo-provera

Outcome Measure Data

Analysis Population Description

Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)

Arm/Group Title	Depo-Provera
Arm/Group Description:	Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Overall Number of Participants Analyzed	53
Mean (Standard Error); Unit of Measure: Aggregate Score from Immunohistochemistr
	-1.12 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Depo-Provera
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.001
	Comments	[Not Specified]
	Method	Paired t-test
	Comments	[Not Specified]

Adverse Events

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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.
Adverse Event Reporting Description	This study had no Serious Adverse Events (SAEs).
Arm/Group Title	Depo-Provera
Arm/Group Description	Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
All-Cause Mortality
	Depo-Provera
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Depo-Provera
	Affected / at Risk (%)
Total	0/68 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Depo-Provera
	Affected / at Risk (%)
Total	39/68 (57.35%)
Blood and lymphatic system disorders
Leukocytes 1	2/68 (2.94%)
Hemoglobin 1	14/68 (20.59%)
Lymphatics - Other 1	2/68 (2.94%)
Edema: Limb 1	2/68 (2.94%)
Endocrine disorders
Hot Flashes 1	1/68 (1.47%)
Gastrointestinal disorders
Vomiting 1	2/68 (2.94%)
Constipation 1	2/68 (2.94%)
Nausea 1	6/68 (8.82%)
Diarrhea 1	2/68 (2.94%)
General disorders
Fever 1	1/68 (1.47%)
Rigors/Chills 1	1/68 (1.47%)
Fatigue 1	6/68 (8.82%)
Pain - Other 1	1/68 (1.47%)
Pain: Breast 1	2/68 (2.94%)
Pain: Uterus 1	1/68 (1.47%)
Pain: Head/Headache 1	2/68 (2.94%)
Pain: Extremity-Limb 1	6/68 (8.82%)
Pain: Rectum 1	1/68 (1.47%)
Pain: Abdominal Pain Nos 1	2/68 (2.94%)
Immune system disorders
Allergy/Immunology - Other 1	1/68 (1.47%)
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis) 1	1/68 (1.47%)
Metabolism and nutrition disorders
Metabolic/Laboratory - Other 1	1/68 (1.47%)
Bilirubin 1	4/68 (5.88%)
Hyponatremia 1	1/68 (1.47%)
Hyperglycemia 1	6/68 (8.82%)
Hypokalemia 1	2/68 (2.94%)
Nervous system disorders
Mood Alteration - Depression 1	2/68 (2.94%)
Mood Alteration - Anxiety 1	4/68 (5.88%)
Renal and urinary disorders
Urinary Retention 1	1/68 (1.47%)
Reproductive system and breast disorders
Breast Function 1	1/68 (1.47%)
Libido 1	1/68 (1.47%)
Irregular Menses 1	1/68 (1.47%)
Vaginal Discharge 1	1/68 (1.47%)
Respiratory, thoracic and mediastinal disorders
Dyspnea 1	2/68 (2.94%)
Skin and subcutaneous tissue disorders
Injection Site Reaction 1	2/68 (2.94%)
Rash 1	2/68 (2.94%)
Pruritus 1	1/68 (1.47%)
Vascular disorders
Hemorrhage, Gu - Vagina 1	7/68 (10.29%)
1 Term from vocabulary, CTCAE (3.0)

Limitations and Caveats

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[Not Specified]

More Information

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: Jessalyn Reboy

Organization: Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-7738

EMail: reboyj@norgoncology.org

Responsible Party:	Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00064025 History of Changes
Other Study ID Numbers:	GOG-0211; NCI-2012-02539 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000306440; GOG-0211 ( Other Identifier: Gynecologic Oncology Group ); GOG-0211 ( Other Identifier: CTEP ); U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted:	July 8, 2003
First Posted:	July 9, 2003
Results First Submitted:	January 31, 2014
Results First Posted:	August 15, 2014
Last Update Posted:	April 11, 2016