Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver
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|ClinicalTrials.gov Identifier: NCT03366155|
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : April 24, 2020
Many people with colorectal cancer get liver metastases. Standard treatment for this is a combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective. A device that does this a pump that delivers drugs over 2 weeks at constant rate into the hepatic artery. The person s body temperature causes the drug to flow from the pump. Researchers want to see if this helps people with colorectal metastases to the liver.
To study the effectiveness of a hepatic artery infusion pump at treating colorectal metastases to the liver.
Adults at least 18 years old with colorectal metastases to the liver
Participants will be screened with:
Heart, blood, and urine tests
Participants will stay in the hospital a few days. A small plastic tube (catheter) will be inserted in an artery into the liver. The catheter will be attached to the pump. That will lie under the skin on the abdomen. It will be small and participants will be able to feel it.
Participants will get treatment in 28-day cycles.
Every Day 1, they will have physical exam, symptom review, and blood tests.
Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port.
Every 12 weeks, they will have a scan.
Tissue samples may be taken during the study.
When they finish the drug, participants may have the pump removed. They will repeat the Day 1 tests. They will be called every 6 months to see how they are doing.
Sponsoring Institute: National Cancer Institute
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Liver Metastases Colorectal Adenocarcinoma Colorectal Cancer With Hepatic Metastases Colorectal Carcinoma||Device: OneRNA Drug: FUDR-Dex Drug: Oxaliplatin Drug: 5FU Drug: Irinotecan Procedure: HAIP installation Drug: cetuximab Device: Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter||Phase 2|
- Nearly 60% of patients with colorectal cancers will develop liver metastases over the course of their disease.
- Of patients with metastatic colorectal cancer, the liver will be the sole site of recurrence or the survival-limiting site of disease for 20%.
- Liver directed therapy, which has taken many forms over the last several decades, is a potential means to prolong survival for properly selected patients and delay progression at that site.
- Hepatic artery infusion of floxuridine (FUDR) via an implantable hepatic artery infusion pump (HAIP) induces objective clinical response rates of nearly 50% in heavily pretreated patients with metastatic colorectal cancer to the liver.
- The identification of patients likely to respond to HAIP and those likely to suffer pumprelated adverse events is currently unknown, and has limited the wide-spread adoption of this otherwise well tolerated intervention.
-To assess the safety of hepatic artery infusion therapy using the Medtronic pump with the
- Determine the response rate in patients with unresectable metastatic colorectal cancer treated with HAIP chemotherapy as measured by RECIST.
- Histologically or cytologically confirmed colorectal adenocarcinoma metastatic to the liver.
- Patients with liver metastases not amenable to resection to No Evidence of Disease (NED) in one stage.
- Patients must have received systemic chemotherapy.
- Age greater than or equal to 18 years.
- Single arm, phase II study of HAIP chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Phase II Study of Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver|
|Actual Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: 1/Arm 1
HAIP chemotherapy + Systemic chemotherapy
genomic test done on tumor and normal liver biopsy samples taken during baseline and end of treatment
HAIP will be filled with mixture of Floxuridine and Dexamethasone. Pump will perfuse drugs to liver for 14 days. Floxuridine (0.12 mg/kg X pump volume X pump flow rate), Dexamethasone (1 mg/day X pump volume (30) X pump flow rate)
85 mg/m2, IV
2000 mg/m2, IV 46-hour infusion of 5-Flouroucail + 400mg/m2, IV of Leucovorin
150 mg/m2, IV
Procedure: HAIP installation
HAIP pump installation
Device: Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter
implanted Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter
- Response rate RR [ Time Frame: at progression ]The fraction of patients who experience a PR or CR using the study treatment
- Hepatic progression-free survival [ Time Frame: at progression ]The fraction of patients whose tumors in liver shrunk after therapy
- Extra-hepatic progression-free survival [ Time Frame: at progression ]The fraction of patients whose tumors outside liver shrunk after therapy
- Overall survival [ Time Frame: death ]Median amount of time subject survives after therapy
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): NCT03366155
|Contact: Cathleen E Hannah||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Jonathan M Hernandez, M.D.||National Cancer Institute (NCI)|