Progression Free Survival
| Group | Value (months) |
|---|---|
| Arm I (Octreotide Acetate and Everolimus) | 14.0 |
| Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 16.7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States, Canada
1 trial · 1 completed · 1 with posted results
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
NCT0122994315 Oct 2010 to 3 Jan 2018
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
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.
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.
Outcomes the sponsor listed as primary.
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| Arm I (Octreotide Acetate and Everolimus) | 14.0 |
| Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 16.7 |
| Group | Value (percentage of participants) |
|---|---|
| Arm I (Octreotide Acetate and Everolimus) | 12 |
| Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 31 |
| Group | Value (months) |
|---|---|
| Arm I (Octreotide Acetate and Everolimus) | 35.0 |
| Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 36.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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. Everolimus: Given PO Octreotide Acetate: Given IM | – | 20 / 74 | 73 / 74 |
| 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. Bevacizumab: Given IV Everolimus: Given PO Octreotide Acetate: Given IM | – | 31 / 73 | 72 / 73 |
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