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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025349
• Other study ID #: TMUH-01-09-09
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2009
• Last updated: December 2, 2009
• Start date: January 2005
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan: Center for Drug EvaluationTaiwan: Department of HealthTaiwan: Institutional Review BoardTaiwan: National Bureau of Controlled Drugs
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Caprioni F, Fornarini G. Bevacizumab in the treatment of metastatic colorectal cancer. Future Oncol. 2007 Apr;3(2):141-8. Review. — View Citation

Chu E. Bevacizumab targeted therapy: validation of angiogenesis as a key target for advanced colorectal cancer. Clin Colorectal Cancer. 2004 May;4(1):16. — View Citation

Eniu A. Integrating biological agents into systemic therapy of breast cancer: trastuzumab, lapatinib, bevacizumab. J BUON. 2007 Sep;12 Suppl 1:S119-26. Review. — View Citation

Jubb AM, Hurwitz HI, Bai W, Holmgren EB, Tobin P, Guerrero AS, Kabbinavar F, Holden SN, Novotny WF, Frantz GD, Hillan KJ, Koeppen H. Impact of vascular endothelial growth factor-A expression, thrombospondin-2 expression, and microvessel density on the treatment effect of bevacizumab in metastatic colorectal cancer. J Clin Oncol. 2006 Jan 10;24(2):217-27. Epub 2005 Dec 19. — View Citation

Link JS, Waisman JR, Nguyen B, Jacobs CI. Bevacizumab and albumin-bound paclitaxel treatment in metastatic breast cancer. Clin Breast Cancer. 2007 Oct;7(10):779-83. — View Citation

Miller KD, Sweeney CJ, Sledge GW Jr. Redefining the target: chemotherapeutics as antiangiogenics. J Clin Oncol. 2001 Feb 15;19(4):1195-206. Review. — View Citation

Moy B, Goss PE. Lapatinib: current status and future directions in breast cancer. Oncologist. 2006 Nov-Dec;11(10):1047-57. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		every 3 months	Yes
Secondary	Time to Progression(TTP), Progression free survival, overall survival, safety, Quality of Life		every 3 months	Yes