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Trial record 18 of 2906 for:    Neuroendocrine Neoplasm | Neuroendocrine Tumors

Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

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.
 
ClinicalTrials.gov Identifier: NCT00137774
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : April 9, 2013
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE August 26, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date April 9, 2013
Study Start Date  ICMJE November 2004
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
Official Title  ICMJE A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
Brief Summary The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2005)
34
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137774
Other Study ID Numbers  ICMJE 04-272
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew H. Kulke, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Genentech, Inc.
  • Schering-Plough
Investigators  ICMJE
Principal Investigator: Matthew H. Kulke, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP