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Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01120158
First received: May 5, 2010
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Bevacizumab
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biweekly Paclitaxel Plus Bevacizumab as First Line Treatment for Older Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Toxicity assessment every month ] [ Designated as safety issue: Yes ]
  • Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Paclitaxel/Bevacizumab
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.
Other Name: Avastin
Drug: 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.
Other Names:
  • Taxoprol
  • Paxene
  • Taxol
  • Ovapac

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120158

Contacts
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr

Locations
Greece
University General Hospital of Alexandroupolis Recruiting
Alexandroupolis, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Stelios Kakolyris, MD         
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Nikos Ziras, MD         
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Aris Polyzos, MD         
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106442666    secretary@horg.gr   
Principal Investigator: Nikos Malamos, MD         
401 Military Hospital of Athens Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Charalampos Christophillakis, MD         
Air Forces Military Hospital of Athens Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Nikos Kentepozidis, MD         
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Stelios Giassas, MD         
University Hospital of Crete Recruiting
Heraklion, Greece
Contact: Dora Hatzidaki    +302810392570    dorachat@med.uoc.gr   
Contact: Eva Maragkoudaki    +302810392857    dorachat@med.uoc.gr   
Sub-Investigator: Manolis Saloustros, MD         
State General Hospital of Larissa, Dep of Medical Oncology Recruiting
Larissa, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Athanasios Athanasiadis, MD         
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Ioannis Boukovinas, MD         
"Diabalkaniko" hospital, Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Christos Emmanouilidis, MD         
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01120158     History of Changes
Other Study ID Numbers: CT/08.31
Study First Received: May 5, 2010
Last Updated: June 21, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Breast cancer
Elderly
Chemotherapy
Anti-angiogenesis therapy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014