Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137774
• Other study ID #: 04-272
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2005
• Last updated: April 7, 2013
• Start date: November 2004
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2012
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Insitute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Massachusetts General Hospital, Schering-Plough

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors		2 years	No
Secondary	To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population		TBD	No