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Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754351
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):
Vassilis Georgoulias, MD, University Hospital of Crete

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Bevacizumab Drug: Docetaxel Drug: Gemcitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer
Study Start Date : September 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
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 Name: Avastin

Drug: Docetaxel
Docetaxel (IV) 65 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Other Name: Taxotere

Drug: Gemcitabine
Gemcitabine (IV) 1500 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Other Name: Gemzar

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]
  2. Toxicity profile [ Time Frame: 21 days ]
  3. Overall Survival [ Time Frame: 1 year ]
  4. Quality of life assessment [ Time Frame: Assessment every two cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00754351

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University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
Sponsors and Collaborators
University Hospital of Crete
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Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete, Dep of Medical Oncology
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Responsible Party: Vassilis Georgoulias, MD, Prof. D. Mavroudis, University Hospital of Crete Identifier: NCT00754351    
Other Study ID Numbers: CT/08.01
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by Vassilis Georgoulias, MD, University Hospital of Crete:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators