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

NCT ID: NCT01067989

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Chemotherapy; Breast Cancer, Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention

same treatment for all patients

Group Type: EXPERIMENTAL

Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

LOVEN DAVID

Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oncology unit

Afula, , Israel

Countries

Israel

Other Identifiers

0078-09-EMC

Identifier Type: -

Identifier Source: org_study_id