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

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

February 28, 2015

Study Completion Date

August 31, 2015

Conditions
Neuroendocrine Carcinoma
Interventions
DRUG

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."

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."

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.

Trial Locations (9)

30901

Medical Oncology Associates of Augusta, Augusta

32804

Florida Hospital Cancer Institute, Orlando

33901

Florida Cancer Specialists, Fort Myers

37203

Tennessee Oncology Associates, Nashville

40207

Baptist Medical Center East, Louisville

45242

Oncology Hematology Care, Inc, Cincinnati

49503

Grand Rapids Oncology Program, Grand Rapids

64132

Research Medical Center, Kansas City

07960

Hematology-Oncology Associates of Northern NJ, Morristown

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER