A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection

This study has been completed.

First Received: December 12, 2005 Last Updated: August 3, 2007 History of Changes

Sponsor:	Adherex Technologies, Inc.
Information provided by:	Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00264446

Purpose

5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will examine the kinetics of inhibition and recovery of the metabolic pathways for fluoropyrimidines in subjects who receive a single oral dose of ADH300004, and may allow optimization of oral 5 FU dosing to subjects in future studies.

Condition	Intervention	Phase
Neoplasms	Drug: ADH300004	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment
Official Title:	Phase 1 Study of the Evaluation of Dihydropyrimidine Dehydrogenase (DPD), Uridine Phosphorylase (UP), Orotate Phosphoribosyl Transferase (OPRT), and Thymidine Phosphorylase (TP) Activity in Tissue Resected From Subjects Undergoing Planned Resection of Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection, Following Administration of Oral ADH300004 (Adherex Protocol Number AHX-03-101)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

Drug Information available for: 5-Ethynyluracil

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed written informed consent
> or = 19 years of age
Patients with histologically confirmed:
- primary or metastatic (known or suspected) colorectal carcinoma requiring planned surgical resection with hepatic biopsy and systemic chemotherapy , or
- primary or metastatic neoplastic disease within the liver from any origin requiring planned surgical resection and systemic chemotherapy
Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing

Exclusion Criteria:

Lack of known or suspected metastatic disease in the liver
Known DPD deficiency
Severe infection
Inability to take oral medication
The need for treatment with any fluoropyrimidine within 8 weeks of any ADH300004 dose
Stroke, major surgery, or other major tissue injury within 30 days before study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264446

Locations

United States, Alabama
UAB - Division of Surgery
Birmingham, Alabama, United States, 35294-3300

Sponsors and Collaborators

Adherex Technologies, Inc.

Investigators

Principal Investigator:

Martin Heslin, MD

University of Alabama at Birmingham

More Information

Additional Information:

Adherex Technologies Inc. Corporate Homepage This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	Adherex Protocol # AHX-03-101
Study First Received:	December 12, 2005
Last Updated:	August 3, 2007
ClinicalTrials.gov Identifier:	NCT00264446 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Adherex Technologies, Inc.:

Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents;
Dihydrouracil dehydrogenase (NADP); Colorectal Carcinoma; Liver Cancer

Additional relevant MeSH terms:

Metabolic Diseases
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
5-ethynyluracil
Dihydropyrimidine Dehydrogenase Deficiency
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions

Intestinal Neoplasms
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Neoplasms
Neoplasms by Site
Digestive System Diseases
Genetic Diseases, Inborn
Therapeutic Uses
Dihydrouracil Dehydrogenase (NADP)
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009