Back to resultsBevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Metastatic Neuroendocrine Tumor, Advanced Neuroendocrine tumor, Bevacizumab, Temozolomide
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Insitute
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Secondary Outcome Measures
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
Full Information
NCT ID
NCT00137774
First Posted
August 26, 2005
Last Updated
April 7, 2013
Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT00137774
Brief Title
Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
Official Title
A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Schering-Plough
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
Metastatic Neuroendocrine Tumor, Advanced Neuroendocrine tumor, Bevacizumab, Temozolomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew H. Kulke, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Insitute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22778320
Citation
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.
Results Reference
result
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Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
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