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Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative 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):
VASSILIKI SXOINA, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00691379
First received: May 29, 2008
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population


Condition Intervention Phase
Breast Cancer
Drug: Carboplatin
Drug: Bevacizumab
Drug: Paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weekly Paclitaxel-carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study

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 (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Toxicity assessment of each chemotherapy cycle ] [ 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: April 2008
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/Carboplatin/Bevacizumab
Drug: Carboplatin
Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
Other Name: Carboplatin
Drug: Bevacizumab
Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
Other Name: Avastin
Drug: Paclitaxel
Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
Other Names:
  • Taxoprol
  • Paxene
  • Taxol

Detailed Description:

Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. 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 to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic breast adenocarcinoma
  • No HER2 overexpression or gene amplification
  • Absent or low ER or PR expression
  • No previous therapy for metastatic breast cancer is allowed
  • 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 (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 nonmelanoma 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: NCT00691379

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: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302106457968    secretary@horg.gr   
Principal Investigator: Stelios Kakolyris, MD         
401 Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302106457968    secretary@horg.gr   
Principal Investigator: Charalampos Christophillakis, MD         
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302810392857    secretary@horg.gr   
Principal Investigator: Aris Polyzos, MD         
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    +302106442666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302810392857    secretary@horg.gr   
Principal Investigator: Nikos Malamos, MD         
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302810392857    secretary@horg.gr   
Principal Investigator: Nikos Ziras, MD         
Air Forces Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +30281392857    secretary@horg.gr   
Principal Investigator: Nikos Kentepozidis, MD         
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302106457968    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: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302106457968    secretary@horg.gr   
Principal Investigator: Athanasios Athanasiadis, MD         
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302106457968    secretary@horg.gr   
Principal Investigator: Ioannis Boukovinas, MD         
"Diabalkaniko" hospital, Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD    +302106448666    secretary@horg.gr   
Contact: Spyros Georgiadis    +302106457968    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: VASSILIKI SXOINA, Prof. D. Mavroudis, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00691379     History of Changes
Other Study ID Numbers: CT/08.02
Study First Received: May 29, 2008
Last Updated: June 21, 2014
Health Authority: Greece: National Organization of Medicines

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

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Carboplatin
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 27, 2014