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Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Vinorelbine
Bevacizumab
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, chemotherapy, anti-angiogenesis therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
  • At least one previous chemotherapy regimen for metastatic breast cancer
  • Age 18-75 years
  • Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  • Performance status (WHO) 0-2
  • Adequate liver function(serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine <1.5 times the upper normal limit) and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • No radiation of measurable disease (except brain metastases)
  • No progressive brain metastases according to clinical or radiological criteria
  • No brain metastases without prior radiation therapy
  • Written informed consent

Exclusion Criteria:

  • Patient unable to take oral medication
  • Active infection
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • History of stroke
  • Anticoagulation therapy (except of low dose aspirin <325mg)
  • Other invasive malignancy except nonmelanoma skin cancer
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women

Sites / Locations

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology
  • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
  • 401 Military Hospital of Athens
  • Air Forces Military Hospital of Athens
  • University Hospital of Crete, Dep of Medical Oncology
  • State General Hospital of Larissa, Dep of Medical Oncology
  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Vinorelbine metronomic + bevacizumab

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Duration of response
Progression free survival
Overall survival

Full Information

First Posted
June 6, 2008
Last Updated
May 27, 2015
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00694200
Brief Title
Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer
Official Title
Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Patients With Metastatic Breast Cancer. A Multicenter Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Not reached the statistical hypothesis at the interim analysis
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without break plus bevacizumab as salvage treatment in patients with metastatic breast cancer.
Detailed Description
Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, chemotherapy, anti-angiogenesis therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Vinorelbine metronomic + bevacizumab
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Description
Vinorelbine per os 50 mg 3 times a week
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab 10 mg/kg IV every 14 days
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
1 year
Title
Progression free survival
Time Frame
1 year
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically- or cytologically- confirmed metastatic breast adenocarcinoma At least one previous chemotherapy regimen for metastatic breast cancer Age 18-75 years Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) Performance status (WHO) 0-2 Adequate liver function(serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine <1.5 times the upper normal limit) and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function No radiation of measurable disease (except brain metastases) No progressive brain metastases according to clinical or radiological criteria No brain metastases without prior radiation therapy Written informed consent Exclusion Criteria: Patient unable to take oral medication Active infection History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) History of stroke Anticoagulation therapy (except of low dose aspirin <325mg) Other invasive malignancy except nonmelanoma skin cancer Psychiatric illness or social situation that would preclude study compliance Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Mavrudis, MD
Organizational Affiliation
University Hospital of Crete, Dep of Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
University Hospital of Crete, Dep of Medical Oncology
City
Heraklion
Country
Greece
Facility Name
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa,
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer

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