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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the hysterectomy, which is 21-24 days after administration of depo-provera |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the hysterectomy, which is 21-24 days after administration of depo-provera |
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Inclusion Criteria:
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
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
No concurrent aminoglutethimide
No prior cancer treatment that would preclude study therapy
No concurrent bosentan
No concurrent rifampin
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| Name | Affiliation | Role |
|---|---|---|
| Richard Zaino | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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The study was activated on 4/12/2004 and closed to accrual on 9/2/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Depo-Provera | Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Medroxyprogesterone |
| Drug |
Given IM |
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| Therapeutic Conventional Surgery | Procedure | Undergo surgical hysterectomy |
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| 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. | During the hysterectomy , which is 21-24 days after administration of depo-provera |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Depo-Provera | Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy and had histologic response data) | Posted | Number | percentage of participants | During the hysterectomy, which is 21-24 days after administration of depo-provera |
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| Secondary | 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. | Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy) | Posted | Mean | Standard Error | Aggregate Score from Immunohistochemistr | During the hysterectomy, which is 21-24 days after administration of depo-provera |
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| Secondary | 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. | Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy) | Posted | Mean | Standard Error | Aggregate Score from Immunohistochemistr | During the hysterectomy , which is 21-24 days after administration of depo-provera |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Depo-Provera | Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy | 0 | 68 | 39 | 68 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy/Immunology - Other | Immune system disorders | CTCAE (3.0) |
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| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Fever | General disorders | CTCAE (3.0) |
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| Rigors/Chills | General disorders | CTCAE (3.0) |
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| Fatigue | General disorders | CTCAE (3.0) |
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| Injection Site Reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Hot Flashes | Endocrine disorders | CTCAE (3.0) |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
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| Hemorrhage, Gu - Vagina | Vascular disorders | CTCAE (3.0) |
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| Inf Unknown Anc: Skin (Cellulitis) | Infections and infestations | CTCAE (3.0) |
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| Lymphatics - Other | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Edema: Limb | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Metabolic/Laboratory - Other | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Bilirubin | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Mood Alteration - Depression | Nervous system disorders | CTCAE (3.0) |
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| Mood Alteration - Anxiety | Nervous system disorders | CTCAE (3.0) |
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| Pain - Other | General disorders | CTCAE (3.0) |
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| Pain: Breast | General disorders | CTCAE (3.0) |
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| Pain: Uterus | General disorders | CTCAE (3.0) |
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| Pain: Head/Headache | General disorders | CTCAE (3.0) |
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| Pain: Extremity-Limb | General disorders | CTCAE (3.0) |
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| Pain: Rectum | General disorders | CTCAE (3.0) |
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| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
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| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) |
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| Breast Function | Reproductive system and breast disorders | CTCAE (3.0) |
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| Libido | Reproductive system and breast disorders | CTCAE (3.0) |
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| Irregular Menses | Reproductive system and breast disorders | CTCAE (3.0) |
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| Vaginal Discharge | Reproductive system and breast disorders | CTCAE (3.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessalyn Reboy | Gynecologic Oncology Group Statistical and Data Center | 716-845-7738 | reboyj@norgoncology.org |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
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| 60-69 years |
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| 70-79 years |
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| 80-89 years |
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