FDUR SUMMARY
Sterile FDUR
Sterile FUDR (floxuridine), an antineoplastic antimetabolite, is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. Each vial contains 500 mg of floxuridine which is to be reconstituted with 5 mL of sterile Water for Injection. An appropriate amount of reconstituted solution is then diluted with a parenteral solution for intra-arterial infusion (see DOSAGE AND ADMINISTRATION section). Floxuridine is a fluorinated pyrimidine.
FDUR (Floxuridine INTRA-ARTERIAL) is indicated for the following:
FUDR is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.
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NEWS HIGHLIGHTS
Published Studies Related to Fdur (Floxuridine)
Phase I/II study of intraperitoneal floxuridine and platinums (cisplatin and/or carboplatin). [1997.08]
Previous studies have shown that intraperitoneal (i.p.) floxuridine (FUDR) is tolerated at a dose of 3 g x 3 days given in 1.5-2 L of normal saline (NS). In a randomized phase II trial by the Southwest Oncology Group, this treatment was selected for further study because of a favorable 1-year progression-free survival.
Intraperitoneal mitoxantrone or floxuridine: effects on time-to-failure and survival in patients with minimal residual ovarian cancer after second-look laparotomy--a randomized phase II study by theSouthwest Oncology Group. [1996.06]
A randomized phase II study of intraperitoneal (ip) mitoxantrone or floxuridine (FUDR) was performed for the treatment of minimal residual epithelial ovarian cancer found at second-look laparotomy after initial platinum-based chemotherapy. Entry was to take place within 30 days of reassessment laparotomies, with documentation of peritoneal metastases either microscopic or gross with cytoreduction to less than or equal to 1 cm in largest diameter...
Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases. [1994.11.05]
Very few patients with liver metastases from colorectal cancer can be cured. We have investigated whether a treatment to slow the growth of liver metastases, hepatic-artery infusion of floxuridine, improves palliation in this setting...
Phase II study of hepatic arterial floxuridine, leucovorin, and dexamethasone for unresectable liver metastases from colorectal carcinoma. [1994.11]
PURPOSE: To determine the toxicity, response rate, and survival of a regimen of hepatic arterial floxuridine (FUDR) with leucovorin (LV) and dexamethasone (Dec) for the treatment of unresectable hepatic metastases from colorectal carcinoma... CONCLUSION: The addition of Dec to hepatic arterial FUDR and LV reduces biliary toxicity while maintaining an excellent response rate and survival. We recommend that this treatment be studied further.
A pilot study of hepatic artery floxuridine combined with systemic 5-fluorouracil and leucovorin. A potential adjuvant program after resection of colorectal hepatic metastases. [1993.03.15]
BACKGROUND. Most patients with colorectal carcinoma metastatic to the liver have relapses after surgical resection of hepatic metastases with failures divided equally between hepatic and extrahepatic sites.Eight patients treated with this regimen as adjuvant therapy after liver metastasis resection were alive and disease-free after a median follow-up of 23 months.
Clinical Trials Related to Fdur (Floxuridine)
Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer [Recruiting]
This phase I trial studies the side effects and best dose of veliparib when given together
with floxuridine in treating patients with metastatic epithelial ovarian, primary peritoneal
cavity, or fallopian tube cancer. Veliparib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as floxuridine,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving veliparib together with floxuridine may kill more tumor
cells
Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Hepatic arterial infusion uses a catheter to carry
cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can
find tumor cells and carry tumor-killing substances to them without harming normal cells.
Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and
radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain
after surgery.
PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine
when given as a hepatic arterial infusion together with gemcitabine hydrochloride and
radiolabeled monoclonal antibody therapy and to see how well it works in treating liver
metastases in patients with metastatic colorectal cancer.
Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma [Recruiting]
This pilot clinical trial studies the safety and effectiveness of continuous hepatic
arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other
chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that
cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more
directly to liver tumors and reduces side effects. HAI alone or in combination with
oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with
locally advanced cholangiocarcinoma.
Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers [Recruiting]
This study is to determine whether intraperitoneal Floxuridine is effective in the patients
with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of
pre- and post-surgery chemotherapies.
Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver [Recruiting]
RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances
directly into the liver. Drugs used in chemotherapy work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
floxuridine and dexamethasone directly into the arteries around the tumor together with
combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine
and dexamethasone works when given together with combination chemotherapy in treating
patients with colorectal cancer that has spread to the liver.
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