Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer
A Phase II Evaluation of Combination Bevacizumab (NCI-Supplied Agent: NSC #70486) and Temsirolimus (CCI-779, NCI-Supplied Agent, NSC #683864) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
4 other identifiers
interventional
53
1 country
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2008
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 28, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2011
CompletedResults Posted
Study results publicly available
August 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2016
CompletedJuly 23, 2019
July 1, 2019
2.9 years
July 25, 2008
May 11, 2015
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
Progression-free Survival at 6 Months
Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Every other cycle for 6 months
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Every cycle and 30 days after the last treatment, an average of 5 years.
Secondary Outcomes (8)
Progression-Free Survival
Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Overall Survival
From entry into the study to death or the date of last contact, up to 5 years
Complete and Partial Tumor Response by RECIST 1.0 by Performance Status
Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
Progression-free Survival at 6 Months by Performance Status
Every other cycle for 6 months
Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type
Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
- +3 more secondary outcomes
Study Arms (1)
Treatment (bevacizumab, temsirolimus)
EXPERIMENTALPatients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22.
Interventions
Given IV
Given IV
Eligibility Criteria
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
- +55 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (41)
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545-1470, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, 49546, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Centerpoint Medical Center LLC
Independence, Missouri, 64057, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65804, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Women's Cancer Care Associates LLC
Albany, New York, 12208, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Gynecologic Oncology Network
Greenville, North Carolina, 27834, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela M. Kuras, Associate Director of Data Management
- Organization
- NRG Oncology Statistics and Data Management Center - Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Edwin Alvarez
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 28, 2008
Study Start
September 1, 2008
Primary Completion
July 15, 2011
Study Completion
January 25, 2016
Last Updated
July 23, 2019
Results First Posted
August 5, 2015
Record last verified: 2019-07