Metastatic Colorectal CancerPhase 2NCT02345746
Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis
A Phase 2 study testing Oxaliplatin, Folinic Acid and 5-Fluorouracil in people with Metastatic Colorectal Cancer, run by Western Regional Medical Center.
Trial summary
In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Oxaliplatin, Folinic Acid and 5-Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2013
- 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 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 refuse surgery
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- Loss of response to at least two lines of systemic chemotherapy including FU, Oxaliplatin or irinotecan 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. Women of childbearing potential must take adequate precautions to prevent pregnancy during treatment.
- Patient consent must be obtained prior to entrance onto study
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.
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- History of thrombophilia, recurrent DVTs, diagnosis of phospholipid syndrome.
- Past or current history of malignancy other than colon 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 or leptomeningeal metastases requiring immediate intervention.
About this study
Official title: Phase 2 Study of Hepatic Arterial Infusion With Oxaliplatin, Folinic Acid and 5 Fluorouracil Alone or in Combination With Intravenous Chemotherapy in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Colorectal Cancer
In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy.
Read the detailed description
In this phase II study, investigators will combine the HAI with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy. We hypothesize that combination therapy 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 Colorectal Cancer
- Being tested
- Oxaliplatin, Folinic Acid, 5-Fluorouracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Eloxatin®
infusion over 12 hours via HAI
Folinic AcidDrug
Also called Leucovorin
as a 2-hour infusion via HAI on day 2
5-FluorouracilDrug
Also called 5-FU
Following Folinic Acid as a continuous infusion over 48 hours on days 2, 3
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Artery Infusion | Experimental | Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine response rate
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 posted26 Jan 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Waypa, Western Regional Medical Center
- Investigators
- Jiaxin Niu, MD, Principal investigator, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345746
- Sponsor's protocol ID
- 12-19
- Status last verified
- Aug 2017
- First submitted
- 12 Jun 2013
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Hepatic Arterial Infusion With Oxaliplatin, Folinic Acid and 5 Fluorouracil Alone or in Combination With Intravenous Chemotherapy in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02345746
- Acronym / sponsor ID
- 12-19
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: patient population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Jan 2015 (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.
In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy.
Detailed description
In this phase II study, investigators will combine the HAI with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy. We hypothesize that combination therapy 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 |
|---|---|---|
| Hepatic Artery Infusion | Experimental | Drug: Oxaliplatin, Drug: Folinic Acid, Drug: 5-FluorouracilHepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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 |
|---|---|---|
| OxaliplatinAlso: Eloxatin®infusion over 12 hours via HAI | Drug | Hepatic Artery Infusion |
| Folinic AcidAlso: Leucovorinas a 2-hour infusion via HAI on day 2 | Drug | Hepatic Artery Infusion |
| 5-FluorouracilAlso: 5-FUFollowing Folinic Acid as a continuous infusion over 48 hours on days 2, 3 | Drug | Hepatic Artery Infusion |
Primary outcome
Determine response rate
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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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.
Jiaxin Niu, MD principal investigator
Western Regional Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Folinic Acid and 5-Fluorouracil in people with Metastatic Colorectal Cancer, run by Western Regional Medical Center.
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 15 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: withdrawn, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 (time frame: one year). 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 24 Aug 2017.