Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Adenocarcinoma

Carcinoma, Adenosquamous

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Adenosquamous Carcinoma of the Endometrium

Ovarian Cancer

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Medroxyprogesterone Acetate

Medroxyprogesterone

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Contraceptive Agents, Male

Antineoplastic Agents, Hormonal

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.

National Cancer Institute (NCI)

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

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Cystadenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Adenocarcinoma of the Appendix

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Doxorubicin

Liposomal doxorubicin

Cisplatin

Lenograstim

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Adjuvants, Immunologic

Immunologic Factors

Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) SC or pegfilgrastim on days 2-11.

Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride

Filgrastim

Pegfilgrastim

Howard Homesley

Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.

OBJECTIVES:

I. Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel.

II. Compare short and long-term toxic effects of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy field (pelvic vs extended field). Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery. Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy treatment arms.

Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or pegfilgrastim on days 2-11.

Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this study within 5.2 years.

Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma

Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.

Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.

Intention to treat among eligible participants who receive random treatment allocation.

Eastern Cooperative Oncology Group

Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.

Treatment randomization following RT.

doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11

Arm 1

Treatment randomization following RT:

doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12

Arm 2

Treatment randomization following RT.

radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11

Treatment randomization following RT:

radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12

Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)

Radiation (RT) Only

Total

Age, Continuous

Angela M. Kuras, Associate Director of Data Management

Primary outcome is measured as a treatment hazard ratio stratified by stage and assuming proportional hazards.

Recurrence-free survival hazard ratio: Arm 2 is relative to Arm 1.

Alive, Recurrence-Free

Recurrence or Death

Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.

Sarcoma

Sarcoma, Endometrial Stromal

Disease Attributes

Neoplasms, Connective and Soft Tissue

Endometrial Stromal Tumors

Uterine Diseases

Soft Tissue Sarcoma

Endometrial Stromal Sarcoma

Trebananib

Angiogenesis Inhibitors

Growth Inhibitors

Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Kathleen Moore

This phase II trial studies the side effects and how well trebananib works in treating patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of endometrial cancer by blocking blood flow to the tumor.

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with AMG 386 (trebananib).

II. To determine the nature and degree of toxicity of AMG 386 in this cohort of patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with AMG 386.

OUTLINE:

Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

A Phase II Trial of AMG 386, a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium

Whether or not the patient survived progression-free for at least 6 months.

Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The observed length of life from entry into the study to death or the date of last contact.

The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Trebananib: Given IV

Treatment (Trebananib)

40 - 49 years

50 - 59 years

60 - 69 years

70 - 79 years

Linda Gedeon for Michael Sill, PhD.

Progression-free Survival > 6 Months

Objective Tumor Response (Complete or Partial Response)

Fatigue

Anemia

Constipation

Hypertension

Nausea

Abdominal Pain

Edema Limbs

Anorexia

Peripheral Sensory Neuropathy

Cough

Diarrhea

Hyperglycemia

Hyponatremia

Hypoalbuminemia

Dyspnea

Vomiting

Ascites

Bloating

Lymphedema

Thromboembolic Event

Localized Edema

Number of patients who did not experience the specified AE.

Grade 0

Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0

Grade 1 (CTCAE v 4.0)

Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0

Grade 2 (CTCAE v 4.0)

Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0

Grade 3 (CTCAE v 4.0)

Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0

Grade 4 (CTCAE v 4.0)

Number of patients who experienced a grade 5 event using common terminology criteria version 4.0

Grade 5 (CTCAE v 4.0)

Adverse Events as Assessed by NCI CTCAE v 4.0

Overall Survival

Progression-free Survival

Carcinoma, Squamous Cell

Adenocarcinoma, Mucinous

Patients undergo EBRT to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.

Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy as in Arm I.

Undergo 3-dimensional conformal radiation therapy

3-Dimensional Conformal Radiation Therapy

Intensity-Modulated Radiation Therapy

Internal Radiation Therapy

Jonathan M Feddock

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

PRIMARY OBJECTIVES:

I. To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina.

SECONDARY OBJECTIVES:

I. To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.

II. To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.

III. To estimate the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy.

IV. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy\* or low-dose rate interstitial brachytherapy\*.

ARM II: Patients undergo EBRT as in Arm I and receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy\* as in Arm I.

NOTE: \*IMRT boost is allowed for patients who are not candidates for brachytherapy. IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis and/or the boost in patients not undergoing brachytherapy. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every month for 3 months, 3 months for 2 years and then every 6 months for 3 years.

Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

The number of participants with disease progression or death from study entry to progression or death. Participants who experienced progression or death were reported by treatment arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer	NCT00006011	Endometrial Ade... Endometrial Ade... Endometrial Cle... Endometrial End... Endometrial Ser... Stage III Uteri...	Doxorubicin Hyd... Cisplatin Filgrastim Pegfilgrastim Paclitaxel	-	GOG Foundation
Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer	NCT01210222	Endometrial Ade... Endometrial Ade... Endometrial Cle... Endometrial End... Endometrial Ser... Endometrioid St... Recurrent Uteri...	Trebananib	18 Years -	GOG Foundation
Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer	NCT00492778	Endometrial End... Endometrial Muc... Endometrial Squ... Recurrent Endom... Recurrent Endom... Recurrent Endom... Recurrent Endom... Recurrent Uteri...	3-Dimensional C... Cisplatin Intensity-Modul... Internal Radiat...	-	GOG Foundation
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
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer	NCT00006011	Endometrial Ade... Endometrial Ade... Endometrial Cle... Endometrial End... Endometrial Ser... Stage III Uteri...	Doxorubicin Hyd... Cisplatin Filgrastim Pegfilgrastim Paclitaxel	-	GOG Foundation

Spots Global Cancer Trial Database for endometrial endometrioid adenocarcinoma, variant with squamous differentiation