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

Primary Purpose

Chemotherapy, Breast Cancer, Metastatic

Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy focused on measuring metronomic chemotherapy, anti-angiogenic effect, Breast cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

same treatment for all patients

Outcomes

Primary Outcome Measures

To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)

Secondary Outcome Measures

Plasma Levels of angiogenic growth factors

Full Information

First Posted
February 11, 2010
Last Updated
July 6, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT01067989
Brief Title
Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer
Official Title
Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
No satisfactory acrual
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy, Breast Cancer, Metastatic
Keywords
metronomic chemotherapy, anti-angiogenic effect, Breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
same treatment for all patients
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
Intervention Description
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)
Primary Outcome Measure Information:
Title
To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Plasma Levels of angiogenic growth factors
Time Frame
At 4 predetermined time points along treatment period.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Oncology unit
City
Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

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

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