NCT01121939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2010

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

September 23, 2015

Completed
Last Updated

February 5, 2016

Status Verified

January 1, 2016

Enrollment Period

4.8 years

First QC Date

May 10, 2010

Results QC Date

February 26, 2015

Last Update Submit

January 8, 2016

Conditions

Neuroendocrine Carcinoma

Keywords

advanced neuroendocrineGastrointestinalBevacizumabAvastinPertuzumabOmnitarg2C4SandostatinOctreotide

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    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.

    18 months

Secondary Outcomes (4)

  • Define Toxicity and Safety

    18 months

  • Progression-Free Survival (PFS)

    18 months

  • Overall Survival (OS)

    18 months

  • Disease Control Rate

    18 months

Study Arms (1)

1

EXPERIMENTAL

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

Drug: BevacizumabDrug: PertuzumabDrug: Sandostatin LAR® Depot

Interventions

BevacizumabDRUG

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.

Also known as: Avastin
1
PertuzumabDRUG

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.

Also known as: Omnitarg, 2C4
1
Sandostatin LAR® DepotDRUG

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.

Also known as: Octreotide
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 0-2.
  • 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
  • +6 more criteria

You may not qualify if:

  • 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).
  • 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.
  • History of myocardial infarction or unstable angina \<=6 months prior to beginning treatment.
  • 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.
  • New York Heart Association (NYHA) grade II or greater congestive
  • heart failure (CHF).
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Medical Oncology Associates of Augusta

Augusta, Georgia, 30901, United States

Location

Baptist Medical Center East

Louisville, Kentucky, 40207, United States

Location

Grand Rapids Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Hematology-Oncology Associates of Northern NJ

Morristown, New Jersey, 07960, United States

Location

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States

Location

Tennessee Oncology Associates

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

BevacizumabpertuzumabOctreotide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptides

Results Point of Contact

Title
John D Hainsworth, MD
Organization
Sarah Cannon Research Institute
asksarah@scresearch.net
1-877-691-7274

Study Officials

  • Johanna C Bendell, S.B., M.D.

    SCRI Development Innovations, LLC

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

February 5, 2016

Results First Posted

September 23, 2015

Record last verified: 2016-01

Locations

US(9)