Phase Ib Study of the Safety and Pharmacokinetics of Chemoembolization With Irinotecan-Eluting Beads for the Treatment of Hepatic Metastases
- Clinical evidence suggests that hepatic chemoembolization may prolong survival in
patients with hepatic metastases.
- Early studies have indicated that chemoembolization using irinotecan drug eluting beads
may be more effective in treating hepatic metastases from colon or melanoma primary
- Primary Objective:
--To determine the safety of hepatic chemoembolization with drug-eluting beads
containing 100mg of irinotecan
- Secondary Objectives:
- To determine the serum pharmacokinetics and tumor tissue concentrations achieved
following hepatic chemoembolization with irinotecan-eluting beads
- Patients > 18 years of age with pathologically proven hepatic metastases from the
gastrointestinal tract, or melanoma with unresectable hepatic lesions.
- Patients whose extent of hepatic metastases represents < 60% of total liver volume AND
whose extrahepatic metastatic disease is determined to be minimal
- Patients must be ECOG performance status of less than or equal to 2 and a life
expectancy of more than 3 months.
- Patients must have adequate organ function.
- Patients must not have had chemotherapy, radiation therapy, or biological therapy for
at least 4 weeks prior to starting study treatments.
- Patients are not to receive conventional chemotherapy or therapeutic monoclonal
antibodies while on study.
- Patients must not have an acute, critical illness.
- A Phase Ib trial in which patients undergo hepatic chemoembolization with drug-eluting
beads containing 100mg irinotecan.
- Up to 15 patients will be enrolled over 1 year to accrue 10 evaluable patients.
- Patients will undergo up to 3 chemoembolizations.
- Following chemoembolization, patients will have serial serum pharmacokinetic samples
drawn and tumor biopsies in order to measure serum and tumor tissue concentrations of
- Patients will be followed for one year after completion of the last treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety of hepatic chemoembolization with drug-eluting beads containing 100mg of irinotecan
Elliot B Levy, M.D.
National Institutes of Health Clinical Center (CC)
United States: Federal Government
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