A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine
OBJECTIVES:
Primary
- 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.
Secondary
- 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
therapy
- 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
combination
- 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
MTD
Type of Study:
Interventional
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:
Yes
Principal Investigator
Yun I. Yen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Institutional Review Board
Study ID:
05122
NCT ID:
NCT00547547
Start Date:
April 2006
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
| South Pasadena Cancer Center | South Pasadena, California 91030 |
