Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

Phase 2

Completed

• Conditions: Neuroendocrine Tumors

• Registration Number: NCT00137774
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-07
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-30
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-07
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors	2 years

Secondary Outcome Measures

Name	Time	Method
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Insitute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States