Metastatic Breast CancerPhase 2NCT01937507
Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer
A Phase 2 study testing HAI with FOLFOX in people with Metastatic Breast Cancer, run by Western Regional Medical Center at 1 site in United States.
Trial summary
Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- HAI with FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance status ECOG 0-2 and a life expectancy of >3 months.
- Patients were required to have measurable disease in the liver, defined as lesions measuring >1 cm in largest diameter on spiral-computed tomography (CT) or magnetic resonance imaging (MRI)
- Histologically confirmed metastatic advanced solid tumors involving the liver, liver replacement less than 70%
- No bevacizumab (avastin) use within 4 weeks prior to enrollment.
- Absence of portal vein thrombosis
- Not a surgical candidate or patients refuge surgery at the time of enrollment
Show all 14Show fewer
- Loss of response to at least 1 line of systemic chemotherapy in metastatic setting
- An asymptomatic extra-hepatic disease is allowed, provided that the extent of the metastatic disease in the liver represented the bulk of the metastatic disease.
- History of liver-directed therapy is eligible at the investigator's discretion.
- Adequate renal function with a calculated creatinine clearance greater than 60 mL/min.
- Hepatic function as follows: Total Bilirubin ≤3 mg/dL, AST ≤5 times upper normal reference value, or ALT ≤ 5 times upper normal reference value.
- Adequate bone marrow function (ANC ≥1500 cells/uL; PLT ≥ 100,000 cells/uL) before each therapy.
- At least three weeks from previous immunotherapy, chemotherapy or radiotherapy before being enrolled in this study.
- All females in childbearing age MUST have a negative serum HCG test unless patients have prior hysterectomy.
Who cannot join
- Clinical or radiographic evidence of moderate amount of ascites.
- History of cirrhosis with Child-Pugh class B or C.
- Pregnant or lactating females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Patients receiving any other investigational agents.
- Patients with bleeding diathesis (clinical bleeding, prothrombin time =/> 1.5 X upper institutional normal value, INR =/> 1.5, activated partial thromboplastin time aPTT =/> 1.5 X upper institutional normal value), active gastric or duodenal ulcer.
Show all 11Show fewer
- History of thrombophilia, recurrent DVTs, diagnosis of phospholipid syndrome.
- Past or current history of malignancy other than breast cancer with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- Patients with clinically significant cardiovascular disease: myocardial infarction or unstable angina within 6 months, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris, clinically significant peripheral vascular disease
- Patients have untreated brain metastasis requiring or leptomeningeal metastases.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Regional Medical Center Inc
Goodyear, Arizona, 85338
About this study
Official title: Pilot Study of Hepatic Arterial Infusion (HAI) With Oxaliplatin, Folinic Acid and 5 Fluorouracil (FOLFOX) in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Breast Cancer
Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting.
Read the detailed description
In this pilot study, the investigators will deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting. The investigators hypothesize that HAI chemotherapy will be able to convert some patients to surgical resection candidates, or/and to overcome chemo-resistance of liver metastases to systemic i.v. chemotherapy for some clinically fit, heavily pre-treated patients.
- Conditions
- Metastatic Breast Cancer
- Being tested
- HAI with FOLFOX
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAI with FOLFOXDrug
Also called Hepatic Artery Infusion
HAI with FOLFOX q 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| HAI with FOLFOX | Experimental | Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid Receives: Drug: HAI with FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Response Rate (RR) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.
To determine response rate (RR) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Measured: One year
Determine Time to Intra-hepatic Progression (TIP) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.
To determine time to intra-hepatic progression (TIP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Measured: One year
Extra-hepatic Progression (TEP) of HAI With Oxaliplatin/5-FU
To determine time to extra-hepatic progression (TEP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Measured: One year
Secondary outcomes (1)
To Document the Toxicity, Tolerability of the Therapy in This Population.
Document the toxicity and tolerability of the therapy using the following CBC with differential, BUN, creatinine, liver function tests,CA 15-3, CA 27.29, Circulating tumor cells (CTCs)and Restaging radiographic studies (MRI or CT liver protocol).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: PI Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiaxin Niu, MD, Principal investigator, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937507
- Sponsor's protocol ID
- 12-20
- Status last verified
- Jan 2018
- First submitted
- 24 Jun 2013
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Hepatic Arterial Infusion (HAI) With Oxaliplatin, Folinic Acid and 5 Fluorouracil (FOLFOX) in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Breast Cancer
- ClinicalTrials.gov ID
- NCT01937507
- Acronym / sponsor ID
- 12-20
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 8 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting.
Detailed description
In this pilot study, the investigators will deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy in metastatic setting. The investigators hypothesize that HAI chemotherapy will be able to convert some patients to surgical resection candidates, or/and to overcome chemo-resistance of liver metastases to systemic i.v. chemotherapy for some clinically fit, heavily pre-treated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAI with FOLFOX | Experimental | Drug: HAI with FOLFOXHepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Performance status ECOG 0-2 and a life expectancy of >3 months.
- Patients were required to have measurable disease in the liver, defined as lesions measuring >1 cm in largest diameter on spiral-computed tomography (CT) or magnetic resonance imaging (MRI)
- Histologically confirmed metastatic advanced solid tumors involving the liver, liver replacement less than 70%
- No bevacizumab (avastin) use within 4 weeks prior to enrollment.
- Absence of portal vein thrombosis
Key exclusion criteria (11 listed)
- Clinical or radiographic evidence of moderate amount of ascites.
- History of cirrhosis with Child-Pugh class B or C.
- Pregnant or lactating females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Patients receiving any other investigational agents.
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 |
|---|---|---|
| HAI with FOLFOXAlso: Hepatic Artery InfusionHAI with FOLFOX q 3 weeks | Drug | HAI with FOLFOX |
Primary outcome
Determine Response Rate (RR) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.
Time frame: One year
To determine response rate (RR) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Determine Time to Intra-hepatic Progression (TIP) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.
Time frame: One year
To determine time to intra-hepatic progression (TIP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Extra-hepatic Progression (TEP) of HAI With Oxaliplatin/5-FU
Time frame: One year
To determine time to extra-hepatic progression (TEP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
1 secondary outcome
To Document the Toxicity, Tolerability of the Therapy in This Population.
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Jiaxin Niu, MD principal investigator
Western Regional Medical Center
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 HAI with FOLFOX in people with Metastatic Breast Cancer, run by Western Regional Medical Center at 1 site in United States.
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 14 inclusion and 11 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 7 Feb 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determine Response Rate (RR) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver. (time frame: One year). The study lists 3 primary outcomes in all. 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 7 Feb 2018.