Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery
This randomized phase II trial studies how well everolimus and octreotide acetate with or without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that cannot be removed by surgery and have spread nearby or to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and octreotide acetate together is more effective with or without bevacizumab in treating pancreatic neuroendocrine tumors.
Gastrin-Producing Neuroendocrine Tumor
Malignant Pancreatic Gastrinoma
Malignant Pancreatic Glucagonoma
Malignant Pancreatic Insulinoma
Malignant Pancreatic Somatostatinoma
Pancreatic Alpha Cell Adenoma
Pancreatic Beta Cell Adenoma
Pancreatic Delta Cell Adenoma
Pancreatic G-Cell Adenoma
Pancreatic Polypeptide Tumor
Recurrent Pancreatic Carcinoma
Recurrent Pancreatic Neuroendocrine Carcinoma
Somatostatin-Producing Neuroendocrine Tumor
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Drug: Octreotide Acetate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors|
- PFS [ Time Frame: From study entry to the date of documented progression or death from any cause, up to 3 years ] [ Designated as safety issue: No ]The Kaplan-Meier will be used to estimate the PFS curves within each treatment arm.
- Response rate measured by Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
- Overall survival (OS) [ Time Frame: From registration to time of death, assessed up to 3 years ] [ Designated as safety issue: No ]The Kaplan-Meier will be used to estimate the OS curves within each treatment arm.
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I (octreotide acetate and everolimus)
Patients receive everolimus PO QD on days 1-28 and octreotide acetate IM on day 1.
Other Names:Drug: Octreotide Acetate
Experimental: Arm II (octreotide acetate, everolimus, and bevacizumab)
Patients receive everolimus and octreotide acetate as in Arm I. Patients also receive bevacizumab IV on days 1 and 15.
Other Names:Drug: Octreotide Acetate
Other Names:Biological: Bevacizumab
l. To assess the progression-free survival (PFS) rate of patients with locally advanced or metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus bevacizumab.
I. To compare PFS among treatment arms shown to be efficacious. II. To estimate the overall tumor response rate in patients with metastatic pancreatic neuroendocrine tumors treated with one of two novel regimens.
III. To estimate the overall biochemical response rate (as measured by plasma chromogranin A levels) in patients with metastatic pancreatic neuroendocrine tumors treated with these regimens.
IV. To assess the toxicity of each regimen in patients with metastatic pancreatic neuroendocrine tumors.
V. To assess the overall survival of patients with pancreatic neuroendocrine tumors treated with these regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive everolimus orally (PO) once daily (QD) on days 1-28 and octreotide acetate intramuscularly (IM) on day 1.
ARM II: Patients receive everolimus and octreotide acetate as in Arm I. Patients also receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229943
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|Principal Investigator:||Matthew Kulke||Alliance for Clinical Trials in Oncology|