ChemotherapyPhase 2NCT01067989
Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer
A Phase 2 study testing Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate) in people with Chemotherapy and Breast Cancer, Metastatic, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chemotherapy, Breast Cancer, Metastatic
- What is being tested?
- Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
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
- Being tested
- Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
- Keywords
- metronomic chemotherapy, anti-angiogenic effect, Breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | same treatment for all patients Receives: Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)
Measured: 6 and 12 months
Secondary outcomes (1)
Plasma Levels of angiogenic growth factors
Measured: At 4 predetermined time points along treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: No satisfactory acrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LOVEN DAVID, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067989
- Sponsor's protocol ID
- 0078-09-EMC
- Status last verified
- Jul 2015
- First submitted
- 11 Feb 2010
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01067989
- Acronym / sponsor ID
- 0078-09-EMC
- Conditions
- Chemotherapy, Breast Cancer, Metastatic
- Keywords
- metronomic chemotherapy, anti-angiogenic effect, Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No satisfactory acrual
- Enrolment
- 22 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)same treatment for all patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | intervention |
Primary outcome
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
1 secondary outcome
Plasma Levels of angiogenic growth factors
Time frame: At 4 predetermined time points along treatment period.
Results and safety
The study was stopped early (reason given: No satisfactory acrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate) in people with Chemotherapy and Breast Cancer, Metastatic, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No satisfactory acrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.