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Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137774
First Posted: August 30, 2005
Last Update Posted: April 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech, Inc.
Schering-Plough
Information provided by (Responsible Party):
Matthew H. Kulke, MD, Dana-Farber Cancer Institute
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Matthew H. Kulke, MD, 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 ]

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

Enrollment: 34
Study Start Date: November 2004
Study Completion Date: December 2012
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.
    Drug: Temozolomide
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137774


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Insitute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
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, Inc.
Schering-Plough
Investigators
Principal Investigator: Matthew H. Kulke, MD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Matthew H. Kulke, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137774     History of Changes
Other Study ID Numbers: 04-272
First Submitted: August 26, 2005
First Posted: August 30, 2005
Last Update Posted: April 9, 2013
Last Verified: April 2013

Keywords provided by Matthew H. Kulke, MD, Dana-Farber Cancer Institute:
Metastatic Neuroendocrine Tumor
Advanced Neuroendocrine tumor
Bevacizumab
Temozolomide

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Bevacizumab
Temozolomide
Dacarbazine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action