Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer

Chemotherapy Clinical Trial

Official title:

Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01067989
• Other study ID #: 0078-09-EMC
• Status: Terminated
• Phase: Phase 2
• First received: February 11, 2010
• Last updated: July 6, 2015
• Start date: March 2010
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Low-dose metronomic(LDM)chemotherapy as well as anti-inflammatory agents and bisphosphonates have shown anti-angiogenic properties on tumor vasculature.

This study is meant to test the therapeutic potential of an anti-angiogenic treatment strategy by combining all these agents for metastatic breast cancer patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologic proof of infiltrating duct carcinoma of breast.

• Her-2 negative tumors.

• ECOG performance status: 0-1.

• Presence of measurable disease: primary and/or metastatic.

• CBC showing normal values or any toxicity limited to grade I.

• SMA showing liver and renal functions < 1.5 normal values

• previous treatment with an anthracycline and with a taxane is mandatory either as neoadjuvant/adjuvant treatment or for metastatic disease.

• previous treatment by chemotherapy for metastatic disease is allowed (up to three lines, allowing for MTD Capecitabine to be one of them).

• previous treatment by a bisphosphonate is allowed. However,those patients who up to the study had not received any bisphosphonate and those who had received Clodronate- will receive Pamidronate; those who had been under Pamidronate- will receive Zoledronate; those who had been under Zoledronate- will continue with it."

• The patient's signature on the informed consent.

Exclusion Criteria:

• Her-2 neu positive tumor

• Inability to visit the clinic for outpatient treatment and evaluation

• Active/symptomatic brain metastases.

• ECOG performance status: 2-4.

• Presence of Hand -Foot syndrome, at grade > 2.

• CBC with any grade >2 toxicity

• SMA showing liver functions > 1.5 normal values

• SMA showing renal functions > normal values -Current continuous treatment by steroids or by NSAIDs, or by anti- coagulants for "non protocol" reasons.

• presence of exclusively non-measurable disease (I/E: exclusive bone disease with non-representative tumor markers).

• previous radiotherapy to the "only measurable disease".

• pleural or peritoneal effusion that may represent a "third space".

• history of active peptic ulcer.

• symptomatic coronary heart disease.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer, Metastatic
• Breast Neoplasms
• Chemotherapy

Intervention

Drug:
• Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
Cyclophosphamide Tab. 50mg, 1x1/day, continuously. Capecitabine Tab. 500mg, 1+2/day, continuously. Methotrexate Tab. 2.5mg, 1x2/day, 2 days every week. Celecoxib Tab. 200mg, 1x2/day, continuously. Pamidronate I.V. 90mg, every 4 weeks; or Zoledronate I.V. 4mg, every 4 weeks)

Locations

Country	Name	City	State
Israel	Oncology unit	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)		6 and 12 months	No
Secondary	Plasma Levels of angiogenic growth factors		At 4 predetermined time points along treatment period.	No