Clinical trial NCT00137774: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Keywords: Metastatic Neuroendocrine Tumor
Advanced Neuroendocrine tumor
Bevacizumab
Temozolomide
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Genentech, Inc.
name: Schering-Plough
First posted: 2005-08-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
timeFrame: 2 years
Secondary outcomes:
measure: To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Insitute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew H. Kulke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan JA, Stuart K, Earle CC, Clark JW, Bhargava P, Miksad R, Blaszkowsky L, Enzinger PC, Meyerhardt JA, Zheng H, Fuchs CS, Kulke MH. Prospective study of bevacizumab plus temozolomide in patients with advanced neuroendocrine tumors. J Clin Oncol. 2012 Aug 20;30(24):2963-8. doi: 10.1200/JCO.2011.40.3147. Epub 2012 Jul 9.