Phase 2
N=43
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers
Neuroendocrine Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01121939 ↗Enrolled (actual)
43
Serious AEs
14.0%
Results posted
Sep 2015
Primary outcome: Primary: Objective Response Rate (ORR) — 16; 18; 16 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Pertuzumab (Drug); Sandostatin LAR® Depot (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
16; 18; 16 | — |
| SECONDARY Define Toxicity and Safety |
11; 5; 5; 3; 1; 1 | — |
| SECONDARY Progression-Free Survival (PFS) |
11.96; 5.49 | — |
| SECONDARY Overall Survival (OS) |
NA; 26.4 | — |
| SECONDARY Disease Control Rate |
72; 91; 77 | — |
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.
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 =1500/μL
- Hgb >=9 g/dL
- Platelets >=100,000/μL
- AST/SGOT =50 mL/min
- Patients >=18 years of age.
- Patients must have a life expectancy >12 weeks.
- Patient must be accessible for treatment and follow-up.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed =2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate 150 mmHg and /or diastolic blood pressure >100 mmHg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to Day of study treatment.
- New York Heart Association (NYHA) grade II or greater congestive
heart failure (CHF).
- Serious cardiac arrhythmia requiring medication.
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) =5 years.
- Infection requiring IV antibiotics.
Data sourced from ClinicalTrials.gov (NCT01121939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.