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A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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
and capecitabine.


- 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.

Inclusion Criteria:

- Patients with advanced, biopsy-proven cancer for which there is no standard curative

- Karnofsky Performance status >= 60

- Prior therapy completed at least 3 weeks before protocol treatment initiation with
recovery from any side-effects

- Prior capecitabine and/or irinotecan are allowed if subject did not progress while on
treatment or within 6 months of treatment with these medications either alone or in

- Prior radiation therapy allowed if < 30% of marrow treated

- Alanine aminotransferase (ALT) and alkaline phosphatase with 3x upper limit of normal

- Serum bilirubin within normal limits

- Absolute neutrophil count >= 15000/ul

- Platelet count >= 100,000/ul

- Hemoglobin >= 10 gm/dl - transfusion allowed to achieve this

- Serum creatinine within 1.5 x upper limit of normal

- Ability to understand and sign an IRB approved informed consent

- Ability to use appropriate contraception and no evidence of pregnancy in female
patients of reproductive potential

Exclusion Criteria:

- No significant medical or psychiatric condition that would make treatment unsafe

- No active brain metastases (patients who have treated brain metastases and are stable
off of steroids are eligible)

- Nursing women

- Patients must be able to comply with protocol related studies and follow-up

- Patients who are UGT1a1 7/7 positive will be excluded from the dose escalation
portion of the trial, but may participate in the cohort of patients treated at the

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine

Outcome Time Frame:

After two 21 day cycles of treatment

Safety Issue:


Principal Investigator

Yun I. Yen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific



City of Hope Medical Center Duarte, California  91010
South Pasadena Cancer Center South Pasadena, California  91030