Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer
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
Recurrent Endometrial Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Combination Bevacizumab (NCI-Supplied Agent: NSC #704865, IND #7921) and Temsirolimus (CCI-779, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
- Proportion of patients who survive progression-free [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Proportion of patients who have objective tumor response (complete or partial) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Duration of progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact, up to 5 years ] [ Designated as safety issue: No ]
- Duration of overall survival [ Time Frame: From entry into the study to death or the date of last contact, up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||January 2100 (Final data collection date for primary outcome measure)|
Experimental: Treatment (bevacizumab, temsirolimus)
Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22.
Other Names:Drug: temsirolimus
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.
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.
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.