Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Genentech, Inc.; Massachusetts General Hospital; Schering-Plough
• Treatments: Bevacizumab; Dacarbazine; Temozolomide

Criteria

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