Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis

NCT02345746 | Withdrawn Phase 2

• 1 other identifier: 12-19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Determine response rate

  one year

Study Arms (1)

Hepatic Artery Infusion

EXPERIMENTAL

Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil

Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-Fluorouracil

Interventions

Oxaliplatin DRUG

infusion over 12 hours via HAI

Also known as: Eloxatin®

Hepatic Artery Infusion

Folinic Acid DRUG

as a 2-hour infusion via HAI on day 2

Also known as: Leucovorin

Hepatic Artery Infusion

5-Fluorouracil DRUG

Following Folinic Acid as a continuous infusion over 48 hours on days 2, 3

Also known as: 5-FU

Hepatic Artery Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Regional Medical Center: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jiaxin Niu, MD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: January 26, 2015
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 24, 2017

Record last verified: 2017-08