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

This study has been terminated.

( Lack of funds )

First Received: April 27, 2006 Last Updated: December 12, 2008 History of Changes

Sponsored by:	Adherex Technologies, Inc.
Information provided by:	Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00319683

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment
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:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil 5-Ethynyluracil

U.S. FDA Resources

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

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
National Health Research Institute, Ward Veterans General Hospital
Taipei, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Chiayi, 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:

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

No publications provided

Responsible Party:	Adherex Technologies ( Clinical Study Manager )
Study ID Numbers:	AHX-03-103
Study First Received:	April 27, 2006
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00319683 History of Changes
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)

Study placed in the following topic categories:

Antimetabolites
Anticarcinogenic Agents
Liver Diseases
Digestive System Neoplasms
Immunologic Factors
Carcinoma, Hepatocellular
5-ethynyluracil
Immunosuppressive Agents
Recurrence

Carcinoma
Liver Neoplasms
Digestive System Diseases
Fluorouracil
Dihydrouracil Dehydrogenase (NADP)
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anticarcinogenic Agents
Antimetabolites
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Carcinoma, Hepatocellular
Antineoplastic Agents
Physiological Effects of Drugs
5-ethynyluracil
Liver Neoplasms
Neoplasms by Site
Therapeutic Uses

Digestive System Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Fluorouracil
Dihydrouracil Dehydrogenase (NADP)
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 30, 2009