NCT00137774

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

August 26, 2005

Last Update Submit

April 7, 2013

Conditions

Neuroendocrine Tumors

Keywords

Metastatic Neuroendocrine TumorAdvanced Neuroendocrine tumorBevacizumabTemozolomide

Outcome Measures

Primary Outcomes (1)

  • To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors

    2 years

Secondary Outcomes (1)

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

Interventions

BevacizumabDRUG

Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.

TemozolomideDRUG

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Insitute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related 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 20;30(24):2963-8. doi: 10.1200/JCO.2011.40.3147. Epub 2012 Jul 9.

    PMID: 22778320RESULT

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

BevacizumabTemozolomide

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Matthew H. Kulke, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2005

Study Completion

December 1, 2012

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

US(3)