Status:
COMPLETED
Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 signifi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00137774
Start Date
November 1 2004
End Date
December 1 2012
Last Update
April 9 2013
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Insitute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115