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)
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer [Recruiting]
The purpose of this study is to see how well patients tolerate the side effects of treatment
with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used
together are a useful way of treating cancer. We have studied these drugs and know the best
doses of each when they are used alone. We do not yet know how well the drugs work with each
other. This study will tell us the best doses of each drug when they are given over the same
period of time.
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.
Radiolabeled Monoclonal Antibody, Gemcitabine, and Hepatic Arterial Infusion of Floxuridine in Treating Patients With Metastatic Colorectal Cancer and Liver Metastases [Recruiting]
RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing
substances to them without harming normal cells. Drugs used in chemotherapy, such as
gemcitabine and floxuridine, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Giving radiolabeled
monoclonal antibody therapy together with gemcitabine and floxuridine after surgery may kill
any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of floxuridine when
given as a hepatic arterial infusion together with radiolabeled monoclonal antibody therapy
and gemcitabine in treating patients with metastatic colorectal cancer and liver metastases.
Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in
different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also
stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy
directly into the arteries around the tumor together with bevacizumab may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving floxuridine and dexamethasone as a
hepatic arterial infusion together with bevacizumab works in treating patients with
unresectable primary liver cancer.
Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy and Bevacizumab 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.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of
tumor cells by blocking blood flow to the tumor. Giving floxuridine and dexamethasone
directly into the arteries around the tumor together with combination chemotherapy and
bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine
and dexamethasone given together with irinotecan, leucovorin, oxaliplatin or fluorouracil,
and bevacizumab works in treating patients with colorectal cancer that has spread to the
liver.
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