Bevacizumab in Combination With Temozolomide in Patients... | NCT00137774

Studies
Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

NCT00137774

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Apr 9, 2013Estimated

Enrollment

34Actual

Phase

Phase 2

Conditions

Neuroendocrine Tumors

Interventions

Bevacizumab
Temozolomide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Jul 2005Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 26, 2005

First Submission Date that Met QC Criteria

Aug 26, 2005

First Posted Date

Aug 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2013

Last Update Posted Date

Apr 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew H. Kulke, MD, Principal Investigator, Dana-Farber Cancer InstitutePrincipal Investigator

Lead Sponsor

Dana-Farber Cancer InstituteOTHER

Collaborators

Name	Class
Massachusetts General Hospital	OTHER
Beth Israel Deaconess Medical Center	OTHER
Brigham and Women's Hospital	OTHER
Genentech, Inc.

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	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	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors		2 years

Secondary Outcomes

Measure	Description	Time Frame
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew H. Kulke, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02115	United States
Dana-Farber Cancer Insitute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22778320	Result	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.

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins