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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01121939
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — 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 — 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 — 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.

Study Details

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.

Key Dates

First listed
May 12, 2010
Start date
May 31, 2010
Status verified
Jan 2016
Primary completion
Feb 28, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 18 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Medical Oncology Associates of AugustaAugustaGeorgia30901-
Baptist Medical Center EastLouisvilleKentucky40207-
Grand Rapids Oncology ProgramGrand RapidsMichigan49503-
Research Medical CenterKansas CityMissouri64132-
Hematology-Oncology Associates of Northern NJMorristownNew Jersey07960-
Oncology Hematology Care, IncCincinnatiOhio45242-
Tennessee Oncology AssociatesNashvilleTennessee37203-

Find similar trials in Fort Myers, FL

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Florida Cancer Specialists· Fort Myers, FLFlorida Hospital Cancer Institute· Orlando, FLMedical Oncology Associates of Augusta· Augusta, GABaptist Medical Center East· Louisville, KYGrand Rapids Oncology Program· Grand Rapids, MIResearch Medical Center· Kansas City, MO

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