Clinical Trials Directory

Trials / Completed

CompletedNCT01010126

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

A Phase 2 Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
252 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. SECONDARY OBJECTIVES: I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis. OUTLINE: Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBevacizumabGiven IV
DRUGTemsirolimusGiven IV

Timeline

Start date
2009-09-08
Primary completion
2017-03-13
Completion
2017-03-13
First posted
2009-11-09
Last updated
2019-01-25
Results posted
2019-01-25

Locations

61 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT01010126. Inclusion in this directory is not an endorsement.