Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis
Primary Purpose
Metastatic Colorectal Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oxaliplatin
Folinic Acid
5-Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hepatic Artery Infusion
Arm Description
Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil
Outcomes
Primary Outcome Measures
Determine response rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02345746
First Posted
June 12, 2013
Last Updated
August 22, 2017
Sponsor
Western Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02345746
Brief Title
Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
patient population
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Regional Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hepatic Artery Infusion
Arm Type
Experimental
Arm Description
Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin®
Intervention Description
infusion over 12 hours via HAI
Intervention Type
Drug
Intervention Name(s)
Folinic Acid
Other Intervention Name(s)
Leucovorin
Intervention Description
as a 2-hour infusion via HAI on day 2
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
Following Folinic Acid as a continuous infusion over 48 hours on days 2, 3
Primary Outcome Measure Information:
Title
Determine response rate
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaxin Niu, MD
Organizational Affiliation
Western Regional Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis
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