Trial Outcomes & Findings for Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus (NCT NCT00064025)

NCT ID: NCT00064025

Last Updated: 2016-04-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 75 participants
• Primary outcome timeframe: During the hysterectomy, which is 21-24 days after administration of depo-provera
• Results posted on: 2016-04-11

Participant Flow

The study was activated on 4/12/2004 and closed to accrual on 9/2/2008.

Participant milestones

Measure	Depo-Provera Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Overall Study STARTED	75
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Depo-Provera Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Overall Study Ineligible	4
Overall Study Inevaluable	3

Baseline Characteristics

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

Baseline characteristics by cohort

Measure	Depo-Provera n=68 Participants Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Age, Customized 30-39 years	1 participants n=5 Participants
Age, Customized 40-49 years	3 participants n=5 Participants
Age, Customized 50-59 years	28 participants n=5 Participants
Age, Customized 60-69 years	30 participants n=5 Participants
Age, Customized 70-79 years	3 participants n=5 Participants
Age, Customized 80-89 years	3 participants n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the hysterectomy, which is 21-24 days after administration of depo-provera

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

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.

Outcome measures

Measure	PR Negative (<=0.2) n=8 Participants	PR Positive (>0.2) n=45 Participants
Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative	62.5 percentage of participants	68.9 percentage of participants

SECONDARY outcome

Timeframe: During the hysterectomy, which is 21-24 days after administration of depo-provera

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

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.

Outcome measures

Measure	PR Negative (<=0.2) n=53 Participants	PR Positive (>0.2)
Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression	-0.77 Aggregate Score from Immunohistochemistr Standard Error 0.14	—

SECONDARY outcome

Timeframe: During the hysterectomy , which is 21-24 days after administration of depo-provera

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

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.

Outcome measures

Measure	PR Negative (<=0.2) n=53 Participants	PR Positive (>0.2)
Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression	-1.12 Aggregate Score from Immunohistochemistr Standard Error 0.15	—

Adverse Events

Depo-Provera

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Depo-Provera n=68 participants at risk Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
Immune system disorders Allergy/Immunology - Other	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Blood and lymphatic system disorders Leukocytes	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Blood and lymphatic system disorders Hemoglobin	20.6% 14/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Fever	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Rigors/Chills	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Fatigue	8.8% 6/68 • 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. This study had no Serious Adverse Events (SAEs).
Skin and subcutaneous tissue disorders Injection Site Reaction	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Skin and subcutaneous tissue disorders Rash	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Skin and subcutaneous tissue disorders Pruritus	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Endocrine disorders Hot Flashes	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Gastrointestinal disorders Vomiting	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Gastrointestinal disorders Constipation	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Gastrointestinal disorders Nausea	8.8% 6/68 • 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. This study had no Serious Adverse Events (SAEs).
Gastrointestinal disorders Diarrhea	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Vascular disorders Hemorrhage, Gu - Vagina	10.3% 7/68 • 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. This study had no Serious Adverse Events (SAEs).
Infections and infestations Inf Unknown Anc: Skin (Cellulitis)	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Blood and lymphatic system disorders Lymphatics - Other	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Blood and lymphatic system disorders Edema: Limb	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Metabolism and nutrition disorders Metabolic/Laboratory - Other	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Metabolism and nutrition disorders Bilirubin	5.9% 4/68 • 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. This study had no Serious Adverse Events (SAEs).
Metabolism and nutrition disorders Hyponatremia	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Metabolism and nutrition disorders Hyperglycemia	8.8% 6/68 • 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. This study had no Serious Adverse Events (SAEs).
Metabolism and nutrition disorders Hypokalemia	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Nervous system disorders Mood Alteration - Depression	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Nervous system disorders Mood Alteration - Anxiety	5.9% 4/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Pain - Other	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Pain: Breast	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Pain: Uterus	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Pain: Head/Headache	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Pain: Extremity-Limb	8.8% 6/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Pain: Rectum	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
General disorders Pain: Abdominal Pain Nos	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 2/68 • 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. This study had no Serious Adverse Events (SAEs).
Renal and urinary disorders Urinary Retention	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Reproductive system and breast disorders Breast Function	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Reproductive system and breast disorders Libido	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Reproductive system and breast disorders Irregular Menses	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).
Reproductive system and breast disorders Vaginal Discharge	1.5% 1/68 • 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. This study had no Serious Adverse Events (SAEs).

Additional Information

Jessalyn Reboy

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-7738

Email: reboyj@norgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place