A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma
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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 or disease
Phase 1Phase 2
Adherex Technologies, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases