Expired Study
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Boston, Massachusetts 02115


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

04-272


NCT ID:

NCT00137774


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dana-Farber Cancer Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

34


Enrollment Type:

Actual


Overall Contact Information

Official Name:Matthew H. Kulke, MD
Principal Investigator
Dana-Farber Cancer Institute

Study Dates

Start Date:November 2004
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:July 2005
Primary Completion Type:Actual
Verification Date:April 2013
Last Changed Date:April 7, 2013
First Received Date:August 26, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Time Frame:2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
Time Frame:TBD
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Bevacizumab
Description:Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.
Intervention Type:Drug
Name:Temozolomide
Description: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.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dana-Farber Cancer Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:Massachusetts General Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:22778320

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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