Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Eniluracil

Antimetabolites

Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles

PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. Capecitabine is a commonly used oral fluoropyrimidine.

PCS6422 and capecitabine

Mary Nyberg

Debbie Vidlak

Jean Grem, MD

Ahsan Khan

Patrick Boland, MD

Mohammed Ghalib

Eric Feldman, MD

Celestine Slapnicker

Amit Mahipal, MD

Sharon Goldberg

Alexander Spira, MD

Sian Bigora, Pharm. D

This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.

A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors

Frequency, duration, and severity of DLTs and adverse events (AEs)

To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine

To evaluate the Maximum Plasma Concentration (Cmax) of PCS6422

Frequency, duration and severity of AESIs

Processa Pharmaceuticals

Symptoms and General Pathology

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Fluorouracil

Enzyme Inhibitors

Cola

20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection

20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection

Will be given to either subject pre-operative and metastatic disease

eniluracil

Only if the subject is amenable to surgical resections

conventional colon surgery

Martin J. Heslin, MD

RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor enzymes that break down chemotherapy drugs.

PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer.

OBJECTIVES: I. Determine the enzymatic activity of dihydropyrimidine dehydrogenase (DPD) in peripheral blood mononuclear cells (PBMC), normal mucosa, or normal liver in patients with primary or metastatic colorectal cancer. II. Evaluate the ability of eniluracil to inactivate DPD in the tumor, PBMCs, and normal tissue in this patient population. III. Assess DPD recovery and uracil levels in PBMCs following surgical resection in these patients.

OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to colorectal tumor (primary vs metastatic). Patients are randomized into one of two treatment arms. Arm I: Patients receive oral eniluracil twice daily on days -2 and -1 followed by surgical resection and tissue harvest on day 0. Arm II: Patients receive an oral placebo as in arm I followed by surgical resection and tissue harvest on day 0. Patients are followed weekly for 1 month.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study.

Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer

Evaluation of Dihydropyrimidine Dehydrogenase (DPD) Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil

1. Determine the enzymatic activity of DPD in PBMC's normal mucosa or normal liver and in primary and secondary colorectal cancers
2. Confirm the ability of eniluracil to inactivate DPD in tumors as well as PBMC's and normal tissue
3. Assess DPD recovery and uracil levels in PBMC's at 5-7,12-16,20-24,and 26-30 days postoperatively

To see if at standard clinical doses are capable of inhibiting DPD in Primary and metastatic colorectal cancer in vivo. Since one of the mechanisms of 5-FU(Fluorouracil) tumor resistance is overexpression of DPD,effective inactivation DPD in tumors by eniluracil in this study will be supportive of the use of eniluracil to overcome this type of 5-FU(Fluorouracil) resistance

To evaluate the recovery of DPD and uracil levels at 4 more times in the range of postoperative days 5-7,12-16,20-24,and 26-30.

National Cancer Institute (NCI)

Glaxo Wellcome

University of Alabama at Birmingham

Chief of Surgical Oncology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

Hematinics

Vitamins

Leucovorin

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Arm 1: (weekly, 28-day cycle): Approximately eighty subjects will orally self-administer eniluracil approximately 13 hr (range of 11-16 hr) before receiving 5 FU and leucovorin. The next day they will orally self-administer 5-FU and leucovorin. On the third day, they will orally self-administer leucovorin. The regimen is taken once per week for three consecutive weeks followed by one-week off-treatment.

Arm 2: (bid daily, 21-day cycle): Approximately sixty subjects will self-administer oral capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment

Eniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, \& 15

5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, \& 16

5-Fluorouracil

Leucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, \& 17

Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment

Gray Kirby, PharmD

Anne McKay

The purpose of the study is to determine if eniluracil/5-FU/leucovorin in metastatic breast cancer (MBC) may have efficacy and tolerability advantages over capecitabine monotherapy.

Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer

A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer

Adherex Technologies, Inc.

Gray Kirby/Clinical Project Manager

Substance Related Disorders

Immune System Diseases

Syndrome

Hand-Foot Syndrome

Colonic Neoplasms

Exanthema

Drug Eruptions

Dermatitis

Hypersensitivity

Drug Hypersensitivity

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

William P. Petros, Pharm D

A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).

Primary Objectives

1. To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
2. To assess any eniluracil dose response relationship in prevention of HFS.
3. To evaluate any potential toxicity of eniluracil ointment.

Eniluracil Hand Foot Syndrome

A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)

West Virginia University

Adenocarcinoma

Rectal Neoplasms

Disease Attributes

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients receive fluorouracil IV as a continuous infusion for 28 days.

Patients receive eniluracil/fluorouracil orally twice a day for 28 days.

fluorouracil

John Hines

Randomized phase III trial to compare the effectiveness of fluorouracil given by infusion with that of fluorouracil plus eniluracil given by mouth in treating patients who have metastatic, recurrent, or residual advanced colorectal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if fluorouracil is more effective with or without eniluracil for advanced colorectal cancer

OBJECTIVES:

I. Compare the response rate, response duration, and survival of patients with advanced colorectal cancer treated with oral fluorouracil (5-FU) and eniluracil or with protracted infusion 5-FU.

II. Compare the toxicity of these treatment regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1-2) and measurable disease (yes vs no). Patients are randomized to one of two treatment arms.

ARM I: Patients receive fluorouracil IV as a continuous infusion for 28 days.

ARM II: Patients receive eniluracil/fluorouracil orally twice a day for 28 days.

Treatment continues every 35 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at least every 10 weeks for 1 year.

Fluorouracil With or Without Eniluracil in Treating Patients With Advanced Colorectal Cancer

Phase III Trial Comparing a 28 Day Schedule of Daily Oral 5-FU Plus Eniluracil to Protracted Intravenous Infusion in Previously Untreated Patients With Advanced Colorectal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors	NCT04861987	Advanced Cancer Refractory Canc... Tumor Gastric	PCS6422 and cap...	18 Years -	Processa Pharmaceuticals
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer	NCT00004195	Colorectal Canc...	eniluracil conventional co...	19 Years - 80 Years	University of Alabama at Birmingham
Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer	NCT01231802	Metastatic Brea...	Eniluracil 5-Fluorouracil Leucovorin Capecitabine	18 Years -	Adherex Technologies, Inc.
Eniluracil Hand Foot Syndrome	NCT00827580	Breast Cancer Colon Cancer	Eniluracil	18 Years -	West Virginia University
Eniluracil Hand Foot Syndrome	NCT00827580	Breast Cancer Colon Cancer	Eniluracil	18 Years -	West Virginia University
Fluorouracil With or Without Eniluracil in Treating Patients With Advanced Colorectal Cancer	NCT00003873	Adenocarcinoma ... Adenocarcinoma ... Recurrent Colon... Recurrent Recta... Stage IV Colon ... Stage IV Rectal...	fluorouracil eniluracil	18 Years -	National Cancer Institute (NCI)
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer	NCT00004195	Colorectal Canc...	eniluracil conventional co...	19 Years - 80 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for eniluracil

Every month we try and update this database with for eniluracil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eniluracil

Every month we try and update this database with for eniluracil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eniluracil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.