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Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech
Schering-Plough
Information provided by (Responsible Party):
Matthew H. Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00137774
First received: August 26, 2005
Last updated: April 7, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ]

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

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

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
Study First Received: August 26, 2005
Last Updated: April 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Metastatic Neuroendocrine Tumor
Advanced Neuroendocrine tumor
Bevacizumab
Temozolomide

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Bevacizumab
Antineoplastic Agents, Alkylating
 Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013