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Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01025349
First received: December 1, 2009
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  Purpose

Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer. It works by preventing the formation of new blood vessels (angiogenesis). The drug has been shown to inhibit vascular endothelial growth factor (VEGF) activity. Previous research showed positive findings in other solid tumors that had metastasized. In this study, the investigators are investigating the response of adding bevacizumab to conventional chemotherapy for metastatic breast cancer patients.


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: Bevacizumab, docetaxel, cisplatin
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retrospective Analysis of Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • Response Rate [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Progression(TTP), Progression free survival, overall survival, safety, Quality of Life [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: metastatic breast cancer
Patients with histological or cytological proven metastatic breast cancer were recruited. The previous hormonal therapy for metastatic breast cancer or cytotoxic therapy was allowed. The Her2/Neu over-expressive status should be negative. Patients with brain metastasis are excluded.
 Drug: Bevacizumab, docetaxel, cisplatin

Bevacizumab 8 mg/kg(over 60 minutes) on first day of first cycle, followed by 5 mg/kg on first day of the rest cycles, repeat every 2 weeks.

docetaxel 45 mg/m2(over 60 minutes) on day 1 of each cycle, repeat every 2 weeks.

cisplatin 50 mg/m2(over 4 hours) on day 1 of each cycle, repeat every 2 weeks.

Other Names:
  • bevacizumab: avastin
  • docetaxel: taxotere

Detailed Description:

Targeted chemotherapy has gradually become the mainstay of cancer treatment in present day. Targeted medications such as trastuzumab, bevacizumab and lapatinib have recently been more extensively adopted for many cancers, particularly breast cancer. Among these targeted medications, bevacizumab is a monoclonal antibody acting on vascular endothelial growth factor receptor and it works by preventing the formation of new blood vessels (angiogenesis). Published articles indicated that monotherapy of bevacizumab on breast cancer showed only a 9-17% response rate, while combining with paclitaxel, the treatment outcome appeared to improve progression-free survival and the objective response rate. We are curious about the additive effect of bevacizumab on conventional chemotherapy, the toxicities induced when combined target therapy with conventional chemotherapy and the duration of remission that these treatment could achieve. In this study, we utilized bevacizumab, docetaxel plus cisplatin for metastatic breast cancer patients and furthermore, we are evaluated the treatment response, toxicities and duration of remission as our main goals.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
  • Normal left ventricular ejection fraction (LVEF).
  • Age ≤ 65 years.
  • At least one unidimensionally measurable lesion by imaging studies.
  • AST/ALT 2.5 ULN (< 5 ULN if liver metastases).
  • Serum bilirubin 3 ULN, Serum Creatinine 1.5 ULN.
  • Urine dipstick of proteinuria <2+.
  • Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

  • Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood pressure > 90 mm Hg).
  • Prior exposure to bevacizumab.
  • Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed), except bone metastasis.
  • Evidence of bleeding diathesis or coagulopathy.
  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding six months.
  • Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of bevacizumab with chemotherapy.
  • Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
  • Pregnancy (positive serum pregnancy test) and lactation. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025349

Locations
Taiwan
Taipei Medical University Hospital
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Principal Investigator: Cheng-Jeng Tai, M.D. Section of Hematology-Oncology, Department of Medicine, Taipei Medical University Hospital
  More Information

Publications:

Responsible Party: Cheng-Jeng Tai, M.D., Director., Section of Hematology-Oncology, Department of Medicine, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT01025349     History of Changes
Other Study ID Numbers: TMUH-01-09-09
Study First Received: December 1, 2009
Last Updated: December 2, 2009
Health Authority: United States: Food and Drug Administration
Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs

Keywords provided by Taipei Medical University Hospital:
bevacizumab
metastatic breast cancer
docetaxel

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Bevacizumab
Cisplatin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013