Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breas... | NCT01067989

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

NCT01067989

Sponsor

HaEmek Medical Center, Israel

Status

Terminated

Last Update Posted

Jul 8, 2015Estimated

Enrollment

22Actual

Phase

Phase 2

Conditions

Chemotherapy
Breast Cancer, Metastatic

Interventions

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

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No satisfactory acrual

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Feb 11, 2010

First Submission Date that Met QC Criteria

Feb 11, 2010

First Posted Date

Feb 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2015

Last Update Posted Date

Jul 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	same treatment for all patients	Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)	Drug	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)

Measure	Description	Time Frame
To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)		6 and 12 months

Measure	Description	Time Frame
Plasma Levels of angiogenic growth factors		At 4 predetermined time points along treatment period.

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Oncology unit		Afula		18101	Israel

ID	Term
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide
D000069287	Capecitabine
D008727	Methotrexate
D000068579	Celecoxib
D000077268	Pamidronate
D000077211	Zoledronic Acid

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided