Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

NCT01116219

Lung Cancer

COMPLETED PHASE2

Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy

NCT00533429

Non-small Cell Lung Cancer

COMPLETED PHASE2

Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

NCT00294931

Carcinoma, Small Cell Lung

COMPLETED PHASE2

Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

NCT02909452

Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type +11 more

COMPLETED PHASE1

Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

NCT00402883

Lung Cancer

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuroendocrine Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

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.

Pertuzumab

Intervention Type DRUG

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.

Sandostatin LAR® Depot

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bevacizumab

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.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Avastin Omnitarg 2C4 Octreotide

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. Patients with documented evidence of disease progression.
3. Patients currently receiving or previously treated with single agent Sandostatin LAR® are eligible.
4. Patients must have \>=1 unidimensional measurable lesion definable by

MRI or CT scan. Disease must be measurable per RECIST version 1.1 criteria.
5. Left Ventricular Ejection Fraction (LVEF) \>=50% as determined by either ECHO or MUGA \<=6 weeks prior to study entry.
6. An ECOG Performance Status of 0-2.
7. Laboratory values as follows:

* ANC \>=1500/μL
* Hgb \>=9 g/dL
* Platelets \>=100,000/μL
* AST/SGOT \<=2.5 x ULN or \<=5.0 x ULN in patients with liver metastases
* ALT/SGPT \<=2.5 x ULN or \<=5.0 x ULN in patients with liver metastases
* Bilirubin \<=1.5 x ULN
* Creatinine \<=2.0 mg/dL or calculated creatinine clearance \>=50 mL/min
8. Patients \>=18 years of age.
9. Patients must have a life expectancy \>12 weeks.
10. Patient must be accessible for treatment and follow-up.
11. Women of childbearing potential must have a negative serum or urine pregnancy test performed \<=7 days prior to start of treatment. Women of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
12. Patients must be able to understand the nature of the study and give

written informed consent, and comply with study requirements

Exclusion Criteria

1. Patients with poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, atypical carcinoid, anaplastic carcinoid, and small cell carcinoma are not eligible.
2. Previous treatment with VEGF or EGFR inhibitors.
3. Cytotoxic chemotherapy, immunotherapy or radiotherapy \<=4 weeks prior to study entry.
4. History or known presence of central nervous system (CNS) metastases.
5. Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury \<=4 weeks prior to beginning treatment.
6. Female patients who are pregnant or lactating.
7. History of hypersensitivity to active or inactive excipients of any component of treatment (bevacizumab, sandostatin, and/or pertuzumab).
8. 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).
9. Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
10. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
11. Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) \<=1 month prior to study enrollment.
12. History of myocardial infarction or unstable angina \<=6 months prior to beginning treatment.
13. Inadequately controlled hypertension (defined as systolic blood pressure \>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.
14. New York Heart Association (NYHA) grade II or greater congestive

heart failure (CHF).
15. Serious cardiac arrhythmia requiring medication.
16. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) \<=6 months prior to Day 1 of treatment.
17. History of stroke or transient ischemic attack \<=6 months prior to beginning treatment.
18. Any prior history of hypertensive crisis or hypertensive encephalopathy.
19. History of abdominal fistula or gastrointestinal perforation \<=6 months prior to Day 1 of beginning treatment.
20. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
21. Any known positive test for human immunodeficiency virus, hepatitis C virus or acute or chronic hepatitis B infection.
22. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
23. Use of any non-approved or investigational agent \<=28 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
24. Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS \>=5 years.
25. Infection requiring IV antibiotics.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No