A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors

This study has suspended participant recruitment.
(Lack of funds)
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00264472
First received: December 12, 2005
Last updated: December 12, 2008
Last verified: December 2008
  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 test the safety and effects of oral ADH300004 14 hours prior to oral 5 FU in subjects with refractory solid tumors.


Condition Intervention Phase
Neoplasms
Drug: ADH300004
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 2-Part Phase 1 Study Evaluating the Safety and Anti-Tumor Activity of ADH300004 (Eniluracil) Administered With 5-Fluorouracil (5-FU), and the Pharmacokinetics of 5-FU Given as: 5.0 mg ADH300004 With Escalating Doses of 5-FU Administered Orally 3 Weeks Out of 4 in Subjects With Refractory Solid Tumors (Part 1); or 5.0 mg ADH300004 With 5 FU Administered Orally as a Split Dose for 3 Weeks Out of 4 in Subjects With Hepatocellular Carcinoma, Non-Small Cell Lung Carcinoma, Gastric Cancer, Cervical Cancer, Prostate Cancer, or Breast Cancer (Part 2) (Adherex Protocol Number AHX-03-104)

Resource links provided by NLM:


Further study details as provided by Adherex Technologies, Inc.:

Primary Outcome Measures:
  • Part 1: To determine the DLTs and MTD of the combination of ADH300004 and 5 FU administered orally in a weekly regimen, for 3 weeks with 1 week rest per cycle, in subjects with incurable solid tumors [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Part 2: To determine the DLTs and MTD of the combination of ADH300004 and 5-FU administered orally as a split dose for 3 out of 4 weeks in subjects with HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ADH300004
    5 mg
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • > or = 18 years of age
  • Advanced or metastatic solid tumors:

Part 1: Histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists

Part 2: Histologically proven advanced and/or metastatic solid tumor of one of the following 6 histologies, that is refractory to standard curative therapy or for which no curative therapy exists: HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer

  • Radiologically documented measurable or evaluable (non-measurable) disease
  • Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
  • Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study

Exclusion Criteria:

  • Cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
  • Non-cytotoxic cancer therapy within 14 days prior to study entry
  • Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
  • Ascites that is refractory to conservative management
  • Inability to take oral medication
  • Active peptic ulcer disease
  • Known hypersensitivity to 5-FU or ADH300004
  • Stroke, major surgery, or other major tissue injury within 30 days before study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264472

Locations
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Adherex Technologies, Inc.
Investigators
Principal Investigator: Howard Burris, III, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Study Manager, Adherex Technoloogies
ClinicalTrials.gov Identifier: NCT00264472     History of Changes
Other Study ID Numbers: Adherex Protocol # AHX-03-104
Study First Received: December 12, 2005
Last Updated: December 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Adherex Technologies, Inc.:
Cancer
Tumors
Neoplasms
Anticarcinogenic Agents
Antineoplastic Agents
Dihydrouracil Dehydrogenase (NADP)

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Hepatocellular
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Fluorouracil
Anticarcinogenic Agents
5-ethynyluracil
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 11, 2014