Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Massachusetts General Hospital Beth Israel Deaconess Medical Center Brigham and Women's Hospital Genentech Schering-Plough
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00137774

Purpose

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

Condition	Intervention	Phase
Neuroendocrine Tumors	Drug: Bevacizumab Drug: Temozolomide	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Temozolomide Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	November 2004
Estimated Study Completion Date:	July 2008
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.

Given once daily for one week followed by a one week rest period. This one-week on/one-week off scheduled will be continued as long as there is no disease progression or serious side effects.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137774

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Genentech

Schering-Plough

Investigators

Principal Investigator:

Matthew H. Kulke, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Matthew H. Kulke, MD )
Study ID Numbers:	04-272
Study First Received:	August 26, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00137774 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Metastatic Neuroendocrine Tumor
Advanced Neuroendocrine tumor
Bevacizumab
Temozolomide

Study placed in the following topic categories:

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Antineoplastic Agents, Alkylating
Bevacizumab

Angiogenesis Inhibitors
Alkylating Agents
Temozolomide
Neuroendocrine Tumors

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Bevacizumab
Angiogenesis Inhibitors
Temozolomide
Pharmacologic Actions

Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on May 07, 2009