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.
PRIMARY OBJECTIVES: I. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial cancer. II. To determine the nature and degree of toxicity of this regimen in these patients. SECONDARY OBJECTIVES: I. To determine the duration of PFS and overall survival of patients treated with this regimen. II. To determine the effects of prognostic factors (i.e., performance status, histological subtype, and grade) in patients treated with this regimen. TERTIARY OBJECTIVES: I. To compare the proportion of patients with objective tumor response and PFS at 6 months receiving the combination of bevacizumab and temsirolimus with those for the single agents bevacizumab and temsirolimus using historical controls. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 3 years, for a total of 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Given IV
Given IV
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
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Time frame: 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.
Time frame: Every other cycle for 6 months
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: Every cycle and 30 days after the last treatment, an average of 5 years.
Progression-Free Survival
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time frame: 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
The observed length of life from entry into the study to death or the date of last contact.
Time frame: 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
Complete and Partial Tumor Response by RECIST 1.0
Time frame: 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
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.
Time frame: Every other cycle for 6 months
Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type
Complete and Partial Tumor Response by RECIST 1.0
Time frame: 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 Histologic Type
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.
Time frame: Every other cycle for 6 months
Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade
Complete and Partial Tumor Response by RECIST 1.0
Time frame: 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 Tumor Grade
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.
Time frame: Every other cycle for 6 months
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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
...and 31 more locations