Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

Study Overview
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Brief Summary
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The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.

Detailed Description
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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.

Official Title
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A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Neuroendocrine Tumor, Advanced Neuroendocrine tumor, Bevacizumab, Temozolomide