Colorectal Neoplasms Clinical Trial
Official title:
Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma
Verified date | July 2023 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with the standard medication floxuridine (FUDR), using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable (not removable by surgery) liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma. This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system.
Status | Terminated |
Enrollment | 21 |
Est. completion date | June 14, 2022 |
Est. primary completion date | January 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients = 18 years of age - Histologically confirmed unresectable colorectal adenocarcinoma metastatic to the liver with no definitive clinical or radiographic evidence of extrahepatic disease. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. (OR) - Histologically confirmed unresectable non-metastatic intrahepatic cholangiocarcinoma, with presence of less than 70% liver involvement. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. - ECOG Performance Status of 0 - 1 - Lab Values = 14 days prior to study enrollment: absolute neutrophil count =1,500/mcL AST/ALT < 2.5 x institutional upper limit of normal (ULN) Platelets = 100,000/mcL Creatinine < 1.5 mg/dL HGB > 9 g/dL Total Bilirubin = 1.5 mg/dL - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Prior chemotherapy is acceptable if last dose given = 3 weeks prior to study enrollment. - Any investigational agent is acceptable if last dose administered = 3 months before study enrollment. Exclusion Criteria: - Presence of distant metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. - Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable. - Active infection, hepatic encephalopathy - Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis; surgically-related ascites does not exclude the patient) - Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test =72 hours before surgery) - If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment - Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke - Serious or non-healing active wound, ulcer, or bone fracture - Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen) - Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples include: active substance abuse, active severe EtOH abuse, etc. - Inability to reliably commit to traveling to Lexington, KY every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Michael J Cavnar, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy | The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination. | approximately 4 weeks | |
Secondary | 30-day Postoperative Serious Adverse Events Related to Pump Implantation | Tabulation of CTCAE serious adverse events attributed to pump implantation | 30 days | |
Secondary | 30-day Catheter Malfunction Due to Tubing Disconnect | Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects. | 30 days | |
Secondary | 30-day Catheter Malfunction Due to Inability to Access Pump | Quantify the percent of patients with inability to meet primary outcome due to inability to access pump. | 30 days | |
Secondary | Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function. | Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function. | Approximately 4 weeks | |
Secondary | Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool. | Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated. | Immediate, determined at screening visit | |
Secondary | Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments. | Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated. | Approximately 6 months | |
Secondary | Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments. | The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated. | 6 months | |
Secondary | Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months. | The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated. | 3 months | |
Secondary | Overall Response Rate at 6 Months | RECIST v1.1 will be used to assess overall response rate at 6 months. | 6 months | |
Secondary | Percent of Patients Who Are Downstaged and Undergo Surgery | The percent of patients who are downstaged and undergo surgery will be tabulated. | 6 months | |
Secondary | Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months. | The percentage of patients who remain on pump chemotherapy at 6months will be tabulated. | 6 months |
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