Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Bevacizumab

Pertuzumab

Octreotide

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Hormonal

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.

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.

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.

Sandostatin LAR® Depot

Johanna C Bendell, S.B., M.D.

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.

* 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.

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

Phase II Study of the Combination of Bevacizumab, Pertuzumab, and Sandostatin for Patients With Advanced Neuroendocrine Cancers.

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.

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 - defined by grade 3/4, treatment-related toxicity

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. 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; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.

Genentech, Inc.

SCRI Development Innovations, LLC

Includes adverse events of all grades, regardless of their relationship to study treatment

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.

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.

Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection.

All Patients

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

John D Hainsworth, MD

Typical Carcinoid

Patients with pancreatic islet cell disease

Pancreatic Islet Cell

All patients on study (treatment is same for all patients)

Objective Response Rate (ORR)

Hypertension

Pain

Left ventricular systolic dysfunction

Diarrhea

Anemia

Leukopenia

Define Toxicity and Safety

Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers	NCT01121939	Neuroendocrine ...	Bevacizumab Pertuzumab Sandostatin LAR...	18 Years -	SCRI Development Innovations, LLC
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers	NCT01121939	Neuroendocrine ...	Bevacizumab Pertuzumab Sandostatin LAR...	18 Years -	SCRI Development Innovations, LLC

Spots Global Cancer Trial Database for sandostatin lar® depot