Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed · Phase 2

Conditions studied: Recurrent Endometrial Carcinoma

In brief

This phase II trial is studying the side effects of giving bevacizumab together with temsirolimus and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving bevacizumab together with temsirolimus may kill more tumor cells.

Key facts

Study ID

NCT00723255

Run by

National Cancer Institute (NCI)

People needed

53

Starts

2008-09-01

Expected to finish

2016-01-25

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed endometrial carcinoma (from primary tumor) including any of the following cell types:
• Endometrioid adenocarcinoma
• Serous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Adenocarcinoma not otherwise specified
• Mucinous adenocarcinoma
• Squamous cell carcinoma
• Transitional cell carcinoma
• Mesonephric carcinoma
• Recurrent or persistent disease that is refractory to curative therapy or established treatments
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have ≥ 1 target lesion to assess response as defined by RECIST
• Tumors within a previously irradiated field are designated as "non-target" lesions in the absence of documented disease progression or a biopsy to confirm persistence for ≥ 90 days after completion of radiotherapy
• Must have received 1 prior chemotherapeutic regimen for management of endometrial carcinoma
• May have received 1 additional cytotoxic regimen for management of this disease
• Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, including any active GOG Phase III protocol for patients with endometrial carcinoma
• No history or evidence of CNS disease, including primary brain tumor or any brain metastases upon physical examination
• GOG performance status (PS) 0-2 (for patients who have received 1 prior regimen) OR PS 0-1 (for patients who have received 2 prior regimens)
• ANC ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Sudarshan K Sharma MD Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Saint Vincent Hospital and Health Services — Indianapolis, Indiana, United States
• Community Howard Regional Health — Kokomo, Indiana, United States
• IU Health La Porte Hospital — La Porte, Indiana, United States
• Saint Joseph Regional Medical Center-Mishawaka — Mishawaka, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• South Bend Clinic — South Bend, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Gynecologic Oncology of West Michigan PLLC — Grand Rapids, Michigan, United States
• Lakeland Hospital — Saint Joseph, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Centerpoint Medical Center LLC — Independence, Missouri, United States
• Truman Medical Center — Kansas City, Missouri, United States
• Mercy Hospital Springfield — Springfield, Missouri, United States
• Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield — Springfield, Missouri, United States
• Saint Louis University Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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