Hepatic Cancer Clinical Trial
Official title:
A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy
NCT number | NCT00587067 |
Other study ID # | 02-120 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2003 |
Est. completion date | May 19, 2016 |
Verified date | March 2023 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II study aims to evaluate regional chemotherapy in patients with unresectable primary hepatic malignancy. Specifically, eligible patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service, will undergo hepatic artery pump placement and continuous infusion of FUDR. The protocol includes radiological and biological correlative studies.
Status | Completed |
Enrollment | 34 |
Est. completion date | May 19, 2016 |
Est. primary completion date | May 19, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with a liver mass that is radiographically consistent with HCC and a serum alpha fetoprotein (AFP) > 500 ng/dl do not require biopsy confirmation of the diagnosis. - Patients with HCC or ICC undergoing exploration for a possible curative resection but found to have unresectable disease confined to the liver will be eligible, provided that no intraoperative findings would exclude them and prior informed consent has been obtained (see below). - There must be <70% liver involvement by cancer, and the disease must be considered unresectable. - Patients who have failed ablative therapy will be eligible. - Patients must have a KPS > 60% and be considered candidates for general anesthesia and hepatic artery pump placement. - Patients with chronic hepatitis and/or cirrhosis are eligible - Serum albumin must be >2.5 g/dl and total serum bilirubin must be <1.8 mg/dl based on preoperative laboratory values within 14 days of registration. - WBC must be >3500 cells/mm3 and platelet count must be >100,000/mm3 based on preoperative laboratory values within 14 days of registration. - The international normalized ratio (INR) must be less than 1.5 in patients not on coumadin therapy, based on preoperative laboratory values within 14 days of registration. - Age >_ 18 years. - Female patients cannot be pregnant or lactating. - Patients must be able to understand and sign informed consent. Exclusion Criteria: - Patients who have received prior treatment with FUDR - Patients who have had prior external beam radiation therapy to the liver. - Patients who have a diagnosis of sclerosing cholangitis. - Patients who have a diagnosis of Gilbert's disease. - Patients who have clinical ascites - Patients with hepatic encephalopathy - Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage. - Patients with occlusion of the main portal vein nor of the right and left portal branches Patients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers). Patient with active infection. Female patients who are pregnant or lactating. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Wake Forest University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Response | To assess the efficacy of continuous arterial infusion (HAI) of FUDR (Floxuridine) and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). | Up to 5 years | |
Primary | Number of Patients With Treatment Related Toxicity | Toxicity evaluated and graded according to the National Cancer Institute, CTCAE v4.0 | Up to 5 years | |
Secondary | Disease Progression | Up to 5 years | ||
Secondary | Median Survival | Median Survival from Initiation of Hepatic Arterial Infusion | Up to 5 years |
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