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

Stopped early · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT00319683

Run by

Adherex Technologies, Inc.

Last updated by the study team

2008-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Queens Medical Center — Honolulu, Hawaii, United States
• Johns Hopkins Singapore International Medical Center — Singapore, Singapore
• Chang Gung Memorial Hospital — Chiayi City, Taiwan
• Chung-Ho Memorial Hospital, Kaohsiung Medical University — Kaohsiung City, Taiwan
• National Health Research Institute, Ward Veterans General Hospital — Taipei, Taiwan
• Taipei Veterans General Hospital — Taipei, Taiwan
• Tri-Service General Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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