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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01067989
First received: February 11, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chemotherapy
Breast Cancer, Metastatic
 Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Levels of angiogenic growth factors [ Time Frame: At 4 predetermined time points along treatment period. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
    1. Cyclophosphamide Tab. 50mg, 1x1/day, continuously.
    2. Capecitabine Tab. 500mg, 1+2/day, continuously.
    3. Methotrexate Tab. 2.5mg, 1x2/day, 2 days every week.
    4. Celecoxib Tab. 200mg, 1x2/day, continuously.
    5. Pamidronate I.V. 90mg, every 4 weeks; or Zoledronate I.V. 4mg, every 4 weeks)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067989

Locations
Israel
Oncology unit Not yet recruiting
Afula, Israel, 18101
Contact: David Loven, MD     972-4-6495540     loven_da@clalit.org.il    
Contact: Kevin Isaacs, MD     972-4-6495540     kevin_is@clalit.org.il    
Principal Investigator: David Loven, MD            
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Dr. Loven David, M.D., senior oncologist, Unit of Oncology, HaEmek Medical Center
ClinicalTrials.gov Identifier: NCT01067989     History of Changes
Other Study ID Numbers: 0078-09-EMC
Study First Received: February 11, 2010
Last Updated: February 11, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
metronomic chemotherapy
anti-angiogenic effect
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Methotrexate
Capecitabine
Celecoxib
Pamidronate
Zoledronic acid
Angiogenesis Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013