Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01120158
• Other study ID #: CT/08.31
• Status: Terminated
• Phase: Phase 2
• First received: May 5, 2010
• Last updated: February 22, 2017
• Start date: September 2009
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.

Description:

Elderly individuals make up a large part of the breast cancer population. Older women are more likely than younger women to be diagnosed at a more advanced stage of breast cancer. However, when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Preference should be given to chemotherapeutic drugs with safer profiles regimens, such as weekly taxane, according to the SIOG recommendations. 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: 46
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic breast adenocarcinoma

• No previous therapy (other than hormonal therapy) for metastatic disease is accepted

• 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 (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)

• bone marrow (neutrophils = 1.5x 109 /L, and platelets = 100x 109 /L)

• 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:

• 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 non-melanoma skin cancer

• Psychiatric illness or social situation that would preclude study compliance

• Pregnant or lactating women

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab (IV) 10 mg/kg on day 1 and day 15. Treatment repeats every 28 days. Therapy will continue until maximum response, disease progression or unacceptable toxicity.
• Paclitaxel
Paclitaxel (IV) 120 mg/m2,on day 1 and day 15. Treatment repeats every 28 days Therapy will continue until maximum response, disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis	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	"Metaxa's" Anticancer Hospital of Piraeus, 1st 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	Heraklion
Greece	State General Hospital of Larissa, Dep of Medical Oncology	Larissa
Greece	"Diabalkaniko" hospital, Thessaloniki	Thessaloniki
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	Overall Response Rate		Objective responses confirmed by CT or MRI every 3 months
Secondary	Toxicity profile		Toxicity assessment every month
Secondary	Time to Tumor Progression		1-year
Secondary	Overall Survival		1 year