Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

April 7, 2013 updated by: Matthew H. Kulke, MD, Dana-Farber Cancer Institute

A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors

The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.

Study Overview

Status

Completed

Conditions

Neuroendocrine Tumors

Intervention / Treatment

Detailed Description

Patients will receive temozolomide orally once daily for one week, followed by a one-week rest period. This one-week on/one week off schedule will continue for the duration of treatment unless significant side effects develop.

Bevacizumab will be administered intravenously every other week. After eight weeks (two cycles), a CT scan will be performed to see how treatment affected tumor growth.

Bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help prevent infection.

Blood tests will be done every other week to evaluate any side effects.

Once the study has been completed, a physical exam, vital signs, blood tests, and CT scan will be performed.

Patients will remain on the study as long as they continue to receive benefit from the treatment and there are no serious side effects.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02115
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Insitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
Measurable disease > 1cm by spiral computed tomography (CT) or > 2cm by other radiographic technique
ECOG performance status of 0-2
Life expectancy of > 12 weeks
Prior treatment with chemotherapy is allowed
Total bilirubin < 2.0mg/dl
AST < 5x upper limit of normal (ULN)
Serum creatinine < 2.0mg/dl
Absolute neutrophil count > 1,000/mm3
Platelets > 100,000/mm3
International Normalized Ratio (INR) < 1.5

Exclusion Criteria:

Prior treatment with temozolomide, decarbazine or bevacizumab
Clinically apparent central nervous system metastases or carcinomatous meningitis
Clinically significant cardiovascular disease
Major surgery, open biopsy, or significant traumatic injury within 28 days
Pregnant or breast-feeding women
Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medication
Serious, nonhealing wound, ulcer or bone fracture
Evidence of bleeding diathesis or coagulopathy
History of other disease or metabolic dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Genentech, Inc.

Brigham and Women's Hospital

Schering-Plough

Investigators

Principal Investigator: Matthew H. Kulke, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Chan JA, Stuart K, Earle CC, Clark JW, Bhargava P, Miksad R, Blaszkowsky L, Enzinger PC, Meyerhardt JA, Zheng H, Fuchs CS, Kulke MH. Prospective study of bevacizumab plus temozolomide in patients with advanced neuroendocrine tumors. J Clin Oncol. 2012 Aug 20;30(24):2963-8. doi: 10.1200/JCO.2011.40.3147. Epub 2012 Jul 9.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria