Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers
The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and pertuzumab treatment is of great interest. The primary endpoint of this trial will be response rate. Toxicity and progression-free survival will be obtained and evaluated.
Drug: Sandostatin LAR® Depot
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of the Combination of Bevacizumab, Pertuzumab, and Sandostatin for Patients With Advanced Neuroendocrine Cancers.|
- Determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and sandostatin LAR®. [ Time Frame: 18 months ] [ Designated as safety issue: No ]To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and sandostatin LAR®.
- define the toxicity and safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers
15 mg/kg IV Day 1. The first dose should be administered over 90 minutes. If no adverse reactions occur after the initial dose, the second dose should be administered over a minimum of 60 minutes. If no adverse reactions occur after the second dose, all subsequent doses should be administered over a minimum of 30 minutes. Bevacizumab will be infused prior to pertuzumab.
Other Name: AvastinDrug: Pertuzumab
840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes. Otherwise, pertuzumab should be infused over 60 minutes. Patients should be observed for 30 minutes after completing the pertuzumab infusion.
If a patient misses a dose of pertuzumab for 1 cycle (i.e., 2 sequential cycles or administrations are 6 weeks or more apart), a re-loading dose (840 mg) of pertuzumab should be given. If re-loading pertuzumab is administered, subsequent doses of 420 mg will then be given every 3 weeks, starting 3 weeks later.
Other Names:Drug: Sandostatin LAR® Depot
30 mg will be given every 28 days by IM injection. The dose of sandostatin may be increased, at the discretion of the treating physician, if necessary to control symptoms related to tumor secretion of vasoactive peptides.
Other Name: Octreotide
- To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and sandostatin LAR®.
- To determine the disease control rate (objective response + stable disease), time to treatment progression, progression-free survival, and overall survival in patients with advanced low grade neuroendocrine cancer when treated with bevacizumab, pertuzumab and Sandostatin LAR® treatment.
- To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121939
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33901|
|Florida Hospital Cancer Institute|
|Orlando, Florida, United States, 32804|
|United States, Georgia|
|Medical Oncology Associates of Augusta|
|Augusta, Georgia, United States, 30901|
|United States, Kentucky|
|Baptist Medical Center East|
|Louisville, Kentucky, United States, 40207|
|United States, Michigan|
|Grand Rapids Oncology Program|
|Grand Rapids, Michigan, United States, 49503|
|United States, Missouri|
|Research Medical Center|
|Kansas City, Missouri, United States, 64132|
|United States, New Jersey|
|Hematology-Oncology Associates of Northern NJ|
|Morristown, New Jersey, United States, 07960|
|United States, Ohio|
|Oncology Hematology Care, Inc|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Tennessee Oncology Associates|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Johanna C Bendell, S.B., M.D.||SCRI Development Innovations, LLC|