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”

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

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.

Intervention(s) in this Clinical Trial

• 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.

Primary Measures

• To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
  • Time Frame: TBD
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Dana-Farber Cancer Institute Other

Overall Clinical Trial Officials and Contacts

Matthew H. Kulke, MD Principal Investigator Dana-Farber Cancer Institute  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00137774

Study ID Number: 04-272

ClinicalTrials.gov Identifier: NCT00137774

Health Authority: United States: Food and Drug Administration