A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 34
- Locations
- 6
- Primary Endpoint
- To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Time Frame: 2 years
Secondary Outcomes
- To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
Investigators
Matthew H. Kulke, MD
Principal Investigator
Dana-Farber Cancer Institute