Phase II Study of the Combination of Bevacizumab, Pertuzumab, and Sandostatin for Patients With Advanced Neuroendocrine Cancers.
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Neuroendocrine Carcinoma
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 43
- Locations
- 9
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
* 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with biopsy-proven advanced, unresectable or metastatic, well-differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid, pancreatic islet cell and other well-differentiated neuroendocrine carcinomas.
- •Patients with documented evidence of disease progression.
- •Patients currently receiving or previously treated with single agent Sandostatin LAR® are eligible.
- •Patients must have \>=1 unidimensional measurable lesion definable by
- •MRI or CT scan. Disease must be measurable per RECIST version 1.1 criteria.
- •Left Ventricular Ejection Fraction (LVEF) \>=50% as determined by either ECHO or MUGA \<=6 weeks prior to study entry.
- •An ECOG Performance Status of 0-
- •Laboratory values as follows:
- •ANC \>=1500/μL
- •Hgb \>=9 g/dL
Exclusion Criteria
- •Patients with poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, atypical carcinoid, anaplastic carcinoid, and small cell carcinoma are not eligible.
- •Previous treatment with VEGF or EGFR inhibitors.
- •Cytotoxic chemotherapy, immunotherapy or radiotherapy \<=4 weeks prior to study entry.
- •History or known presence of central nervous system (CNS) metastases.
- •Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury \<=4 weeks prior to beginning treatment.
- •Female patients who are pregnant or lactating.
- •History of hypersensitivity to active or inactive excipients of any component of treatment (bevacizumab, sandostatin, and/or pertuzumab).
- •Patients with proteinuria at screening as demonstrated by urine dipstick for proteinuria \>=2+ (patients discovered to have \>=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate \<=1 g of protein/24 hours to be eligible).
- •Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
- •Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
Arms & Interventions
1
combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers
Intervention: Bevacizumab
1
combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers
Intervention: Pertuzumab
1
combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers
Intervention: Sandostatin LAR® Depot
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: 18 months
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary Outcomes
- Define Toxicity and Safety(18 months)
- Progression-Free Survival (PFS)(18 months)
- Overall Survival (OS)(18 months)
- Disease Control Rate(18 months)