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)
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