Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

June 26, 2012 updated by: Vassilis Georgoulias, MD, University Hospital of Crete

Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer

This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in > 1st line treatment for metastatic breast cancer. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
    • Crete
      • Heraklion, Crete, Greece
        • University Hospital of Crete, Dep of Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
  • No HER2 overexpression or gene amplification
  • At least one previous chemotherapy regimen for metastatic breast cancer
  • Age ≥18 years
  • Performance status (WHO) 0-2
  • Life expectancy of at least 12 weeks
  • Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
  • 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 ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function
  • Written informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Progressive brain metastases according to clinical or radiological criteria
  • Brain metastases without prior radiation therapy
  • Radiation therapy within the previous 4 weeks
  • Previous radiation therapy to the only measurable lesion
  • Proteinuria ≥ 500 mgr of protein daily
  • Uncontrolled hypertension
  • Documented hemorrhagic diathesis or coagulation disorder
  • Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
  • Thrombotic event within the previous 6 months
  • Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
  • Major surgical procedure within the previous 4 weeks
  • Presence of nonhealing wound or fracture
  • Peripheral neuropathy > grade 2 according to the NCI CTCAE (version 3.0)
  • Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
  • Uncontrolled infection
  • Any serious, uncontrolled comorbidity on the investigator's judgment
  • Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer
  • Serious psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Bevacizumab->Docetaxel->Gemcitabine
Drug: Bevacizumab
Bevacizumab (IV) 10 mgr/Kgr on days 1 and 15 every 4 weeks for 6 cycles followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
Other Names:
  • Avastin
Drug: Docetaxel
Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Other Names:
  • Taxotere
Drug: Gemcitabine
Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Quality of life assessment
Time Frame: Assessment every two cycles
Assessment every two cycles
Progression Free Survival
Time Frame: 1 year
1 year
Toxicity profile
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Crete

Investigators

  • Principal Investigator: Dimitris Mavrudis, MD, University Hospital of Crete, Dep of Medical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/08.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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