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

NCT00319683 | Terminated Phase 1

• 1 other identifier: AHX-03-103
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 7

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 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.

Conditions

Hepatocellular Carcinoma

Keywords

Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents; Dihydrouracil Dehydrogenase (NADP)

Interventions

ADH300004 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adherex Technologies, Inc.: lead

Study Sites (7)

Queens Medical Center

Honolulu, Hawaii, 96813, United States

Location

Johns Hopkins Singapore International Medical Center

Singapore, Singapore

Location

Chang Gung Memorial Hospital

Chiayi City, Taiwan

Location

Chung-Ho Memorial Hospital, Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

National Health Research Institute, Ward Veterans General Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Related Links

• Adherex Technologies Inc. Corporate Homepage

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms

Interventions

eniluracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jacqueline Whang-Peng, MD

  National Health Research Institute, Ward Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Last Updated: December 15, 2008

Record last verified: 2008-12

Locations

US (1); TW (5); SG (1)