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

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ClinicalTrials.gov Identifier: NCT00264446
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : August 6, 2007
Sponsor:
Information provided by:
Adherex Technologies, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: ADH300004 Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources





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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00264446     History of Changes
Other Study ID Numbers: Adherex Protocol # AHX-03-101
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: August 6, 2007
Last Verified: August 2007

Keywords provided by Adherex Technologies, Inc.:
Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents;
Dihydrouracil dehydrogenase (NADP); Colorectal Carcinoma; Liver Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Eniluracil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action