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, Transitional Cell

Carcinoma, Squamous Cell

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Endometrial Neoplasms

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

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

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Transitional Cell Carcinoma

Adenocarcinoma of the Appendix

Ovarian Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Dasatinib

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive induction therapy comprising dasatinib PO QD for 14 days. \*Beginning 7 days later, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1, and dasatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Robert Coleman

This pilot phase I trial studies how well dasatinib works together with paclitaxel and carboplatin in treating patients with stage III, stage IV, or endometrial cancer that has come back after a period of improvement. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Giving dasatinib together with paclitaxel and carboplatin may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To evaluate pMEK and EphA2 signaling effectors in pre- and post- treatment biopsy tissues from patients with advanced staged measurable primary or recurrent endometrial cancer.

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 (CTCAE v. 4) of dasatinib administered in combination with paclitaxel and carboplatin in patients with advanced staged measurable primary or recurrent endometrial cancer.

II. To record the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.

III. To describe the progression-free survival and overall survival.

TERTIARY OBJECTIVES:

I. To explore the relationship of micro ribonucleic acid (RNA) 520d-3p (miR520d-3p) and EphA2 in pretreatment biopsies.

II. To evaluate downstream EphA2 signaling effectors, such as CAV-1, pAKT, FAK, paxillin, and p130cas in pre- and post-tissue treatment biopsies.

III. To explore the effect of dasatinib on the expression of other Eph family members such as EphB2 and EphB4.

IV. To quantify circulating tumor cells (CTCs) before and during the individual treatment phases.

OUTLINE:

Patients receive induction therapy comprising dasatinib orally (PO) once daily (QD) for 14 days. \*Beginning 7 days later, patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV on day 1, and dasatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: \* Patients who have had prior external-beam pelvic or extended-field pelvic/para-aortic radiation therapy must receive treatment at a reduced dose.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

Pilot and Translational Study of Dasatinib (NSC#732517) Paclitaxel and Carboplatin in Women With Advanced Stage and Recurrent Endometrial Cancer

Change in pMEK expression will be evaluated.

Summary statistics and box plots will be used to describe the distributions of expression of EphA2 and its downstream signaling effectors.

Best overall response will be tabulated. The proportion of patients with CR and with (CR+PR) will be estimated with 95% confidence intervals.

Estimated with the product-limit estimator of Kaplan and Meier and illustrated with Kaplan-Meier plots.

Descriptive statistics will be used to summarize the number of CTCs for patients with each type of response. Estimate the mean number of CTCs for each of these groups with 95% confidence intervals.

Tabulated by grade and relationship to study drug, stratified by whether or not patients had prior pelvic radiation.

National Cancer Institute (NCI)

Nintedanib

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Don Dizon

This phase II trial studies the side effects and how well nintedanib works in treating patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or 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 without going on a subsequent therapy against the disease for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib).

II. To determine the nature and degree of toxicity of BIBF 1120 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 BIBF 1120.

OUTLINE:

Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. 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.

Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of BIBF 1120 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0

Complete and Partial Tumor Response by RECIST 1.1

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

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

the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.

Gynecologic Oncology Group

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nintedanib: Given PO

Treatment (Nintedanib)

Age, Continuous

30-39 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Linda Gedeon for Michael Sill, PhD

Leukopenia

Neutropenia

Anemia

Other Investigations

Nausea

Vomiting

Other Gastrointestinal

General & Administration site

Infections/infestations

Metabolism/nutrition

Musculoskeletal/connective tissue

Psychiatric

Renal/Urinary

Respiratory/thoracic/mediastinal

Vascular Disorders

Patients on study who experienced adverse events (Grade 3 or higher)

Number of Participants With Adverse Events

Objective Tumor Response

Progression-free Survival > 6 Months

Overall Survival

The time in months that a patient survived progression-free.

Progression Free Survival

Overall Study

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

Immunoglobulin Fc Fragments

Immunologic Factors

Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Dalantercept

Vicky Makker

This phase II trial studies how well dalantercept works in treating patients with endometrial cancer that has come back or is persistent. Dalantercept 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 dalantercept (ACE-041).

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

SECONDARY OBJECTIVES:

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

TERTIARY OBJECTIVES:

I. To measure the expression of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), activin receptor-like kinase 1 (ALK1), endoglin (CD105), and other markers via immunohistochemistry (IHC) and determine if there is correlation between expression and clinical response to treatment.

II. To determine the correlation between ALK1 gene expression, other markers, and clinical response to treatment.

III. To determine the correlation between concentration of VEGF, bone morphogenetic protein 9 (BMP9), bone morphogenetic protein 10 (BMP10), and ALK1 in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay (ELISA), and clinical response to treatment.

IV. To correlate somatic mutations in candidate genes with response to therapy.

OUTLINE:

Patients receive dalantercept subcutaneously (SC) on day 1. Courses repeat every 21 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.

Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Dalantercept, a Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be \< 10 mm in short axis; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

Treatment and Progression-free Survival is defined as the duration alive from study entry until progression is documented, death or non-protocol treatment is initiated; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.

Non-protocol treatment initiation prior to disease progression and prior to 6 months from study entry was counted as an event for treatment and progression-free survival at 6 months. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for treatment and progression-free survival at 6 months.

Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.

Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for progression-free survival at 6 months.

Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.

Duration of survival is defined as the duration alive from study entry until death or last contact.

The frequencies of the maximum grade of any acute adverse event, regardless of attribution are reported during treatment and up to 30 days after stopping the study treatment are reported.

The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported

Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.

Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.

Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Dalantercept: Given SC

Laboratory Biomarker Analysis: Correlative studies

Treatment (Dalantercept)

40-49

50-59

60-69

70-79

United States

Region of Enrollment

Linda Gedeon, BA, CCRP Clinical Research Coordinator

Response

Treatment and Progression-free Survival at 6 Months

Progression-free Survival at 6 Months

Duration of Progression-free Survival

Duration of Survival

Abdominal Distention

Abdominal Pain

Ascites

Constipation

Diarrhea

Gastric Hemorrhage

Rectal Fistula

Rectal Hemorrhage

Edema Face

Edema Limbs

Fatigue

Prolonged activated partial thromboplastin time

Alkaline Phosphatase Increased

Creatinine Increased

Lymphocyte Count Decreased

Weight Loss

Anorexia

Dehydration

Hyperglycemia

Hypoalbuminemia

Hypoglycemia

Hypokalemia

Arthralgia

Back Pain

Myalgia

Dizziness

Headache

Neuralgia

Urinary Tract Obstruction

Dyspnea

Epistaxis

Pleural Effusion

Hypertension

Thromboembolic Event

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 v4.0)

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

Grade 2 (CTCAE v4.0)

Number of patients who experienced a grade 3 event using Common Terminology 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 (Primary Serious and All Other AEs)

Mitogens

Patients receive brivanib alaninate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Brivanib Alaninate

Matthew Powell

This phase II trial is studying how well brivanib alaninate works in treating patients with endometrial cancer that has come back (recurred) or is persistent. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PRIMARY OBJECTIVES:

I. To assess the activity of brivanib (brivanib alaninate) for patients with recurrent or persistent endometrial cancer with the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response..

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival. II. To determine the nature and degree of toxicity of brivanib as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 in this cohort of patients.

TERTIARY OBJECTIVES:

I. To determine whether activating mutations in fibroblast growth factor receptor 2 (FGFR2) are associated with progression-free survival status \> 6 months following brivanib treatment, objective tumor response following brivanib treatment, or endometrioid histology.

II. To explore the associations between select biomarkers and response to brivanib (progression-free survival status \> 6 months and objective tumor response), measures of clinical outcome (progression-free survival and overall survival) or disease status including histologic cell type: i) mutations in FGFR2 or phosphatase and tensin homolog (PTEN) in deoxyribonucleic acid (DNA) from formalin-fixed and paraffin-embedded (FFPE) tumor or normal blood cells; ii) immunohistochemical (IHC) expression of the FGFR family and ligands, steroid receptor isoforms or phosphorylated (p) v-akt murine thymoma viral oncogene homolog 1 (AKT) in FFPE tumor; iii) concentration or the change in the concentration of vascular endothelial growth factor (VEGF) or type IV collagen in pre-cycle 1, pre-cycle 2 and/or pre-cycle 3 plasma.

III. To explore the relationship among the panel of biomarkers evaluated in this cohort: i) mutations in FGFR2 or PTEN; ii) IHC expression of the FGFR family and ligands, steroid receptor isoforms or pAKT; iii) concentration or the change in the concentration of VEGF or type IV collagen.

OUTLINE:

Patients receive brivanib alaninate orally (PO) once daily (QD) on days 1-28. 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.

Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Brivanib (BMS582664), an Oral, Multitargeted Growth Factor Tyrosine Kinase Inhibitor in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer	NCT01440998	Endometrial Ade... Endometrial Cle... Endometrial Muc... Endometrial Ser... Endometrial Squ... Endometrial Tra... Endometrial Und... Endometrioid Ad... Recurrent Uteri... Stage III Uteri... Stage IIIA Uter... Stage IIIB Uter... Stage IIIC Uter... Stage IV Uterin... Stage IVA Uteri... Stage IVB Uteri...	Carboplatin Dasatinib Laboratory Biom... Paclitaxel	18 Years -	National Cancer Institute (NCI)
Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer	NCT01225887	Endometrial Ade... Endometrial Cle... Endometrial Muc... Endometrial Ser... Endometrial Squ... Endometrial Tra... Endometrial Und... Malignant Uteri... Recurrent Uteri...	Nintedanib	18 Years -	GOG Foundation
Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer	NCT01642082	Endometrial Ade... Endometrial Cle... Endometrial Mix... Endometrial Muc... Endometrial Ser... Endometrial Squ... Endometrial Tra... Endometrial Und... Recurrent Uteri...	Dalantercept Laboratory Biom...	18 Years -	GOG Foundation
Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer	NCT00888173	Endometrial Ade... Endometrial Cle... Endometrial Mix... Endometrial Muc... Endometrial Ser... Endometrial Squ... Endometrial Tra... Endometrial Und... Recurrent Uteri...	Brivanib Alanin... Laboratory Biom...	18 Years -	GOG Foundation
Intraperitoneal Paclitaxel, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Stage III-IV Endometrial Cancer	NCT00575952	Endometrial Ade... Endometrial Cle... Endometrial Mix... Endometrial Ser... Endometrial Squ... Endometrial Und... Recurrent Uteri... Stage IIIA Uter... Stage IIIC Uter... Stage IVA Uteri... Stage IVB Uteri...	Cisplatin Doxorubicin Hyd... Filgrastim Paclitaxel Pegfilgrastim	-	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

Spots Global Cancer Trial Database for endometrial squamous cell carcinoma