A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
18 Years
N/A
Both
Neuroendocrine Tumors
Trial Information
A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Matthew H. Kulke, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
04-272
NCT ID:
NCT00137774
Start Date:
November 2004
Completion Date:
December 2012
Related Keywords:
- Neuroendocrine Tumors
- Metastatic Neuroendocrine Tumor
- Advanced Neuroendocrine tumor
- Bevacizumab
- Temozolomide
- Neuroendocrine Tumors
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Dana-Farber Cancer Insitute | Boston, Massachusetts 02115 |
