A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine
- To determine the maximum tolerated dose of high-selenium Brassica juncea (BJ-Se) and
capecitabine when administered in combination with irinotecan hydrochloride in patients
with advanced malignancies.
- To determine the effects of BJ-Se on the pharmacokinetics of irinotecan hydrochloride
- To determine the effect of BJ-Se on the serum selenium and protein profile.
- To correlate response and tolerance to this regimen with expression of key enzymes
involved as targets or with the metabolism of the components of treatment, including
thymidylate synthase and dihydropyrimidine dehydrogenase.
- To evaluate changes to potential selenium related parameters.
OUTLINE: This is a multicenter, dose-escalation study of high-selenium Brassica juncea
(BJ-Se) and capecitabine. The dose of capecitabine is escalated first, followed by dose
escalation of BJ-Se.
Patients receive oral BJ-Se on days -7 to 21 in course 1 and on days 1-21 in all other
courses. Patients also receive irinotecan IV on days 1 and 8 and oral capecitabine twice
daily on days 1-14. Treatment repeats every 21 days in the absence of unacceptable toxicity
or disease progression.
After the maximum tolerated dose (MTD) of capecitabine and BJ-Se are determined, additional
patients are accrued and receive treatment at the MTD. Blood is collected from these
patients during course 1 for pharmacokinetic studies.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine
After two 21 day cycles of treatment
Yun I. Yen, MD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|
|South Pasadena Cancer Center||South Pasadena, California 91030|