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Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

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ClinicalTrials.gov Identifier: NCT00064025
Recruitment Status : Completed
First Posted : July 9, 2003
Results First Posted : August 15, 2014
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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
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
Hide 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
Arm/Group Title Depo-Provera
Hide Arm/Group Description Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Overall Number of Baseline Participants 68
Hide 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%
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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)
Hide 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
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)
Arm/Group Title Depo-Provera
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)
Arm/Group Title Depo-Provera
Hide 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)
Show Statistical Analysis 1 Hide 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]
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
Hide 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   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Depo-Provera
Affected / at Risk (%)
Total   0/68 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide 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  2/68 (2.94%) 
Hemoglobin  14/68 (20.59%) 
Lymphatics - Other  2/68 (2.94%) 
Edema: Limb  2/68 (2.94%) 
Endocrine disorders   
Hot Flashes  1/68 (1.47%) 
Gastrointestinal disorders   
Vomiting  2/68 (2.94%) 
Constipation  2/68 (2.94%) 
Nausea  6/68 (8.82%) 
Diarrhea  2/68 (2.94%) 
General disorders   
Fever  1/68 (1.47%) 
Rigors/Chills  1/68 (1.47%) 
Fatigue  6/68 (8.82%) 
Pain - Other  1/68 (1.47%) 
Pain: Breast  2/68 (2.94%) 
Pain: Uterus  1/68 (1.47%) 
Pain: Head/Headache  2/68 (2.94%) 
Pain: Extremity-Limb  6/68 (8.82%) 
Pain: Rectum  1/68 (1.47%) 
Pain: Abdominal Pain Nos  2/68 (2.94%) 
Immune system disorders   
Allergy/Immunology - Other  1/68 (1.47%) 
Infections and infestations   
Inf Unknown Anc: Skin (Cellulitis)  1/68 (1.47%) 
Metabolism and nutrition disorders   
Metabolic/Laboratory - Other  1/68 (1.47%) 
Bilirubin  4/68 (5.88%) 
Hyponatremia  1/68 (1.47%) 
Hyperglycemia  6/68 (8.82%) 
Hypokalemia  2/68 (2.94%) 
Nervous system disorders   
Mood Alteration - Depression  2/68 (2.94%) 
Mood Alteration - Anxiety  4/68 (5.88%) 
Renal and urinary disorders   
Urinary Retention  1/68 (1.47%) 
Reproductive system and breast disorders   
Breast Function  1/68 (1.47%) 
Libido  1/68 (1.47%) 
Irregular Menses  1/68 (1.47%) 
Vaginal Discharge  1/68 (1.47%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2/68 (2.94%) 
Skin and subcutaneous tissue disorders   
Injection Site Reaction  2/68 (2.94%) 
Rash  2/68 (2.94%) 
Pruritus  1/68 (1.47%) 
Vascular disorders   
Hemorrhage, Gu - Vagina  7/68 (10.29%) 
1
Term from vocabulary, CTCAE (3.0)
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
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