Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Patients With Metastatic Breast Cancer. A Multicenter Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00694200
• Other study ID #: CT/08.03
• Status: Terminated
• Phase: Phase 2
• First received: June 6, 2008
• Last updated: May 27, 2015
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Vinorelbine
Vinorelbine per os 50 mg 3 times a week
• Bevacizumab
Bevacizumab 10 mg/kg IV every 14 days

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Duration of response		1 year	No
Secondary	Progression free survival		1 year	No
Secondary	Overall survival		1 year	No