A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma

This study has been terminated.
(Lack of funds)
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00319683
First received: April 27, 2006
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 locally advanced, recurrent, or metastatic hepatocellular carcinoma.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: ADH300004
Phase 1
Phase 2

Adherex Technologies, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study in Subjects With Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma, Evaluating the Safety, and Anti-Tumor Activity of ADH300004 (Eniluracil) With Escalating Doses of 5 Fluorouracil Administered Orally Once Weekly for 3 Weeks Out of Every 4 (Adherex Protocol Number AHX-03-103)

Resource links provided by NLM:


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

  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
  • In the Phase I portion, Asian subjects that are > or = to 18 years of age
  • In the Phase II portion, any subjects that are > or = to 18 years of age
  • Non-resectable locally advanced, recurrent, or metastatic hepatocellular carcinoma (HCC) that is either histologically proven or a radiologically documented liver mass with: (alpha-fetoprotein [AFP] > 4,000 ng/mL, hepatitis B surface antigen positive or alpha-fetoprotein [AFP] > 400 ng/mL, hepatitis B surface antigen negative)
  • Radiologically documented 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:

  • Chemotherapy, radiotherapy, or any other investigational drug within 28 days prior to study entry
  • No more than 1 previous treatment with systemic chemotherapy (chemotherapy administered as part of a chemo-embolization procedure is not considered systemic chemotherapy)
  • 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
  • History of primary brain tumors or brain metastases
  • Previous or concurrent malignancy at another site within the last 5 years
  • 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: NCT00319683

Locations
United States, Hawaii
Queens Medical Center
Honolulu, Hawaii, United States, 96813
Singapore
Johns Hopkins Singapore International Medical Center
Singapore, Singapore
Taiwan
Chang Gung Memorial Hospital
Chiayi, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
National Health Research Institute, Ward Veterans General Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Adherex Technologies, Inc.
Investigators
Principal Investigator: Jacqueline Whang-Peng, MD National Health Research Institute, Ward Veterans General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Study Manager, Adherex Technologies
ClinicalTrials.gov Identifier: NCT00319683     History of Changes
Other Study ID Numbers: AHX-03-103
Study First Received: April 27, 2006
Last Updated: December 12, 2008
Health Authority: United States: Food and Drug Administration
Singapore: Health Sciences Authority
Taiwan: Department of Health

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Fluorouracil
Dihydrouracil Dehydrogenase (NADP)
Anticarcinogenic Agents
5-ethynyluracil
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014