A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- NCT00319683
- Lead Sponsor
- Adherex Technologies, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Queens Medical Center
🇺🇸Honolulu, Hawaii, United States
Chang Gung Memorial Hospital
🇨🇳Chiayi, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
🇨🇳Kaohsiung, Taiwan
Johns Hopkins Singapore International Medical Center
🇸🇬Singapore, Singapore
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
National Health Research Institute, Ward Veterans General Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan