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A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM

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ClinicalTrials.gov Identifier: NCT03493061
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Yuhong Li, Sun Yat-sen University

Brief Summary:
The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis. The patients will be treated with systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Liver Metastases Drug: Irinotecan Drug: Oxaliplatin Drug: Floxuridine Phase 2

Detailed Description:
Recent studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. Hepatic arterial infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion oxaliplatin could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to determine whether systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic Chemotherapy With Irinotecan Plus Hepatic Arterial Infusion With Floxuridine and Oxaliplatin in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Systemic CPT-11 + HAI (FUDR+L-OHP)

Patients will receive Systemic CPT-11 + HAI (FUDR+L-OHP) every 28 days:

Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; followed by Oxaliplatin 85 mg/m2 over 3 hours through the HAI pump on Day 1 and 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

then Irinotecan 150 mg/m2 IV over 90 minutes on Day 15, followed by Oxaliplatin 85 mg/m2 IV over 3 hours on Day 15.

This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.

Drug: Irinotecan
Irinotecan 150 mg/m2 IV over 90 minutes on Day 1, 15

Drug: Oxaliplatin
Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.

Drug: Floxuridine
0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.




Primary Outcome Measures :
  1. Complete resection rates (R0 resection rates) [ Time Frame: Up to 2-4 months ]
    defined as no macroscopic or microscopic residual tumor



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-70 years old
  • Histologically confirmed colorectal adenocarcinoma
  • Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis
  • Initially unresectable colorectal liver metastasis confirmed by the multidisciplinary team (MDT)
  • With no prior treatment for liver metastasis, including chemotherapy, operation, radiotherapy, transcatheter hepatic arterial chemoembolization (TACE) and targeted therapy
  • Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning
  • With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN
  • Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L
  • Grade A level of Child-Push Liver Function
  • Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance >50ml/min (Cockcroft-Gault Equation)
  • ECOG performance status of 0-2
  • Life expectancy ≥ 3 months
  • Not appropriate for anti-EGFR or any other targeted therapy (with KRAS mutation or could not afford it)
  • Patients have provided a signed Informed Consent Form
  • With good compliance

Exclusion Criteria:

  • With any extra-hepatic metastasis and/or primary tumor recurrence
  • Severe arterial embolism or ascites
  • With hemorrhagic tendency or coagulation disorders
  • Hypertensive crisis or hypertensive encephalopathy
  • Severe and uncontrolled systemic complications such as infections or diabetes.
  • Serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension even with appropriate drug intervention, unstable angina pectoris, congestive heart failure (NYHA 2-4 degree), arrhythmia that needs medication intervention
  • Patient who has suffered from central nervous system diseases such as primary brain tumor, uncontrolled epilepsy even with standard treatment, any brain metastasis or stroke
  • Patient who has a concurrent malignancy or has a malignancy within 5 years before study enrollment, (with the exception of radically resected skin basal cell carcinoma or cervical carcinoma in situ)
  • Patient who has received any investigational antineoplastic agent within 28 days before the enrollment
  • Any residual toxicity from prior chemotherapy (with the exception of alopecia), such as grade 2 or more sensory peripheral neuropathy (NCI CTC v3.0), oxaliplatin-based regimen will not be considered
  • Patient who is allergic to oxaliplatin, leucovorin, 5-Fluorouracil, floxuridine or dexamethasone
  • Pregnant or lactating women
  • Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility
  • Unable or unwilling to comply with the research plan
  • The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493061


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Yuhong, MD    020-87342487    liyh@sysucc.org.cn   
Principal Investigator: Li Yuhong, MD         
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Yuhong Li, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03493061     History of Changes
Other Study ID Numbers: HAI-CRCLM
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Colorectal Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Oxaliplatin
Irinotecan
Floxuridine
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites