Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vassilis Georgoulias, MD, University Hospital of Crete
ClinicalTrials.gov Identifier:
NCT00754351
First received: September 17, 2008
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Bevacizumab
Drug: Docetaxel
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital of Crete:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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

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.

  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 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
  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: NCT00754351

Locations
Greece
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
Investigators
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: Vassilis Georgoulias, MD, Prof. D. Mavroudis, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00754351     History of Changes
Other Study ID Numbers: CT/08.01
Study First Received: September 17, 2008
Last Updated: June 26, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by University Hospital of Crete:
docetaxel
gemcitabine
bevacizumab
chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Gemcitabine
Docetaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 16, 2014