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
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|ClinicalTrials.gov Identifier: NCT01229943|
Recruitment Status : Active, not recruiting
First Posted : October 28, 2010
Results First Posted : February 11, 2016
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Gastrinoma Pancreatic Neuroendocrine Tumor G1 Pancreatic Neuroendocrine Tumor G2 Pancreatic Vipoma Recurrent Pancreatic Neuroendocrine Carcinoma||Biological: Bevacizumab Drug: Everolimus Drug: Octreotide Acetate||Phase 2|
l. To assess the progression-free survival rate of patients with locally advanced or metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus bevacizumab.
I. To compare progression-free survival (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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors|
|Actual Study Start Date :||October 15, 2010|
|Actual Primary Completion Date :||September 1, 2014|
Experimental: Arm I (octreotide acetate and everolimus)
Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.
Drug: Octreotide Acetate
Experimental: Arm II (octreotide acetate, everolimus, and bevacizumab)
Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.
Drug: Octreotide Acetate
- Progression Free Survival [ Time Frame: From study entry to the date of documented progression or death from any cause, up to 3 years ]Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.
- Overall Response Rate [ Time Frame: Up to 3 years ]The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
- Overall Survival (OS) [ Time Frame: From registration to time of death, assessed up to 3 years ]Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229943
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|Principal Investigator:||Matthew H Kulke||Alliance for Clinical Trials in Oncology|