Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Paget's Disease, Mammary

Endometrial Neoplasms

Skin Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Paget Disease of the Breast

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Anticoagulants

Reproductive Control Agents

Other Dietary Supplements

Tamoxifen

Citric Acid

Sodium Citrate

Medroxyprogesterone Acetate

Medroxyprogesterone

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Contraceptive Agents, Male

Citrate

Tamoxifen Plus Medroxyprogesterone Acetate (MPA) x 5 years

medroxyprogesterone

tamoxifen citrate

adjuvant therapy

Ronald K. Potkul, MD

Barbara L. Smith, MD, PhD

RATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen.

PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.

OBJECTIVES:

* Compare endometrial pathologic diagnoses (proliferative changes, simple or cystic hyperplasia, complex adenomatous hyperplasia, hyperplasia with atypia, and carcinoma) in postmenopausal women with breast carcinoma treated with adjuvant tamoxifen who are randomly assigned to medroxyprogesterone acetate (MA) vs observation.
* Compare endometrial pathologic diagnoses (persistent endometrial hyperplasia, atypia, or carcinoma) resulting in tamoxifen discontinuation and intermittent bleeding in patients treated with these regimens.
* Characterize the incidence of spontaneous regression and progression of simple or cystic hyperplasia in these patients.
* Characterize endometrial biopsy results using different endometrial stripe width cut-off points, for cases in which the width is at least 5 mm by endovaginal ultrasound in patients receiving tamoxifen.
* Compare changes over time in endometrial oncogene expression (e.g., c-fos, c-jun, p53, IGF1) and receptor status in patients receiving tamoxifen with or without prior chemotherapy who are randomly assigned to MA vs observation.
* Describe the associations among change in gene expression, receptor status, endometrial abnormality, length of tamoxifen exposure, and prior chemotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to adjuvant chemotherapy (yes vs no), number of positive nodes (0-3 vs at least 4), and endovaginal sonogram endometrial stripe (less than 5 mm vs at least 5 mm). Patients are randomized to 1 of 2 arms.

All patients receive adjuvant oral tamoxifen daily for five years.

* Arm I: Patients undergo observation.
* Arm II: Patients receive oral medroxyprogesterone acetate on days 1-14. Treatment repeats every 3 months for 5 years.

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

PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study.

S9630, Medroxyprogesterone in Treating Women With Breast Cancer

A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III

Endometrial pathologic diagnosis at 2 years after registration

Endometrial pathologic diagnosis at 5 years after registration

National Cancer Institute (NCI)

Cancer and Leukemia Group B

SWOG Cancer Research Network

Symptoms and General Pathology

Recurrence

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

Anti-Infective Agents

Analgesics

Aldesleukin

Interferons

Interleukin-2

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Immunologic Factors

Anti-HIV Agents

Anti-Retroviral Agents

aldesleukin

recombinant interferon alpha-2a

Sylvie Negrier, MD

RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer. Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white blood cells to kill tumor cells. It is not yet known whether giving medroxyprogesterone, interferon, or aldesleukin alone is more effective than giving interferon together with aldesleukin in treating kidney cancer.

PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or aldesleukin to see how well they work when given alone compared to interferon combined with aldesleukin in treating patients with metastatic kidney cancer.

OBJECTIVES:

Primary

* Determine the overall survival of patients with metastatic renal cell adenocarcinoma treated with medroxyprogesterone vs recombinant interferon alfa-2a and/or aldesleukin.

Secondary

* Determine the objective response rate (complete and partial) of patients treated with these regimens.
* Determine the progression-free survival of patients treated with these regimens.
* Determine the toxicity of these regimens in these patients.
* Evaluate the quality of life of patients before and after induction treatment with these regimens (week 10).

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are randomized to 1 of 4 treatment arms.

* Arm I (medroxyprogesterone): Patients receive oral medroxyprogesterone once daily for 12 weeks. Patients may receive a second 12-week course in the presence of responding or stable disease. Quality of life is assessed at baseline and at weeks 12 and 24.
* Arm II (recombinant interferon alfa-2a): Patients receive recombinant interferon alfa-2a subcutaneously (SC) 3 times weekly for 12 weeks. Patients may receive a second 12-week course in the presence of responding or stable disease. Quality of life is assessed as in arm I.
* Arm III (aldesleukin): Patients receive aldesleukin SC twice daily on days 1-5, 8, 9, 15, 16, 22, and 23 and once daily on days 10-12, 17-19, and 24-26. Courses repeat beginning in weeks 6, 13, and 20. Quality of life is assessed at baseline and at weeks 10 and 24.
* Arm IV (recombinant interferon alfa-2a and aldesleukin): Patients receive recombinant interferon alfa-2a as in arm II and receive aldesleukin as in arm III. Quality of life is assessed as in arm III.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 456 patients will be accrued for this study.

Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer

Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO]

Centre Leon Berard

Gland and Hormone Related Diseases

Carcinoma, Adenosquamous

Carcinoma, Endometrioid

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Adenosquamous Carcinoma of the Endometrium

Ovarian Cancer

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.

Laboratory Biomarker Analysis

Therapeutic Conventional Surgery

Richard Zaino

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.

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

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

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.

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.

Gynecologic Oncology Group

This study had no Serious Adverse Events (SAEs).

Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy

Depo-Provera

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Jessalyn Reboy

PR Negative (<=0.2)

PR Positive (>0.2)

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

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

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

Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression

Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression

Overall Study

Herbal and Botanical

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Levonorgestrel

Norgestrel

Cola

Patients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90 days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

Patients receive OCP comprising ethinyl estradiol and norgestrel once daily on days 1-21. Treatment repeats every 28 days for 3-4 courses (3-4 packs of OCP) in the absence of unacceptable toxicity. Approximately 1 week after starting the fourth pack of OCP, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

ethinyl estradiol

norgestrel

laboratory biomarker analysis

Karen Lu

Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer. Hormone therapy may prevent the development of endometrial cancer in women with a genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer.

PRIMARY OBJECTIVES:

I. The primary objective is to evaluate the effect of progesterone therapy versus combination estrogen and progesterone therapy on potential surrogate endpoint biomarkers (SEBs) relevant to endometrial carcinogenesis.

II. To evaluate changes in histology and ultrasound appearance of the endometrium in women with HNPCC after 3 months of progesterone therapy versus combination estrogen and progesterone therapy compared with baseline.

III. To establish a point estimate of the baseline frequency of endometrial abnormalities looking at histological and molecular markers in a cohort of females carrying an HNPCC gene mutation.

OUTLINE: Patients are randomized to 1 of 2 arms.

All patients undergo a baseline transvaginal ultrasound and endometrial biopsy.

Arm I: Patients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90 days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

Arm II: Patients receive oral contraceptive pills (OCP) comprising ethinyl estradiol and norgestrel once daily on days 1-21. Treatment repeats every 28 days for 3-4 courses (3-4 packs of OCP) in the absence of unacceptable toxicity. Approximately 1 week after starting the fourth pack of OCP, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

Patients are followed at 6 weeks and are encouraged to return in 6 months to participate in continued endometrial screening.

Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer

Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC

Hyperplasia

Endometrial Hyperplasia

John P. Curtin, MD

George L. Mutter, MD

Francisco A. R. Garcia, MD, MPH

Richard Zaino, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia.

PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.

OBJECTIVES:

* Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients diagnosed at initial biopsy to have complex atypical hyperplasia.
* Compare the histologic response rates in patients with atypical endometrial hyperplasia treated with oral medroxyprogesterone acetate (Provera) vs intramuscular medroxyprogesterone acetate suspension (Depo-Provera) .

OUTLINE: This is a randomized, two-part study.

* Part A: Patients undergo immediate hysterectomy.
* Part B: Patients are randomized to 1 of 2 arms.

  * Arm I: Patients receive oral medroxyprogesterone acetate (Provera) once daily for 3 months.
  * Arm II: Patients receive medroxyprogesterone acetate suspension (Depo- Provera) intramuscularly once monthly for 3 months (days 1, 31, and 62).

Patients undergo hysterectomy at the end of the third month.

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

PROJECTED ACCRUAL: A minimum of 360 patients for part A and 140 patients (70 per arm) for part B will be accrued for this study.

Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
S9630, Medroxyprogesterone in Treating Women With Breast Cancer	NCT00002920	Breast Cancer Endometrial Can...	medroxyprogeste... tamoxifen citra... adjuvant therap...	18 Years -	SWOG Cancer Research Network
Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer	NCT00416429	Kidney Cancer	aldesleukin recombinant int... medroxyprogeste...	18 Years -	Centre Leon Berard
Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer	NCT00416429	Kidney Cancer	aldesleukin recombinant int... medroxyprogeste...	18 Years -	Centre Leon Berard
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus	NCT00064025	Endometrial Ade... Endometrial Ade... Endometrial End... Recurrent Uteri... Stage I Uterine... Stage II Uterin... Stage III Uteri... Stage IV Uterin...	Laboratory Biom... Medroxyprogeste... Therapeutic Con...	18 Years -	GOG Foundation
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer	NCT00033358	Endometrial Can...	medroxyprogeste... ethinyl estradi... norgestrel laboratory biom...	25 Years - 50 Years	National Cancer Institute (NCI)
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer	NCT00033358	Endometrial Can...	medroxyprogeste... ethinyl estradi... norgestrel laboratory biom...	25 Years - 50 Years	National Cancer Institute (NCI)
Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer	NCT00003179	Endometrial Can...	medroxyprogeste...	-	GOG Foundation
Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer	NCT00416429	Kidney Cancer	aldesleukin recombinant int... medroxyprogeste...	18 Years -	Centre Leon Berard
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus	NCT00064025	Endometrial Ade... Endometrial Ade... Endometrial End... Recurrent Uteri... Stage I Uterine... Stage II Uterin... Stage III Uteri... Stage IV Uterin...	Laboratory Biom... Medroxyprogeste... Therapeutic Con...	18 Years -	GOG Foundation

Spots Global Cancer Trial Database for medroxyprogesterone