High-Selenium Brassica Juncea, Irinotecan, and Capecitabine in Treating Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT00547547|
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : November 6, 2015
RATIONALE: Brassica juncea that contains high amounts of selenium may slow the growth of cancer cells. Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-selenium Brassica juncea together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of high-selenium Brassica juncea and capecitabine when given together with irinotecan in treating patients with advanced cancer.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: high-selenium Brassica juncea Drug: capecitabine Drug: irinotecan hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
|Experimental: Treatment (high-selenium therapy and chemotherapy)||
Dietary Supplement: high-selenium Brassica juncea
Dose Level A: 3200 mcg orally day -7 through duration of treatment. Dose Level B: 4800 mcg orally day -7 through duration of treatment. Dose Level C: 6400 mcg orally day -7 through duration of treatment. Dose Level D: 7200 mcg orally day -7 through duration of treatment. Dose Level E: 8000 mcg orally day -7 through duration of treatment.Drug: capecitabine
Dose Level 1: 750 mg/m2, 2x daily x 14 days every 21 days. Dose Level 1.5: 850 mg/m2, 2x daily x 14 days every 21 days. Dose Level 2: 1000 mg/m2, 2x daily x 14 days every 21 days.Drug: irinotecan hydrochloride
Dose Level 1: 100 mg/m2 on day 1 and day 8 every 21 days. Dose Level -1: 75 mg/m2 on day 1 and day 8 every 21 days.
- Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine [ Time Frame: After two 21 day cycles of treatment ]
- Toxicity [ Time Frame: After two 21 day cycles of treatment ]
- Pharmacokinetics [ Time Frame: For patients treated at the MTD only at the end of cycle one of treatment ]
- Serum selenium and protein profile [ Time Frame: 21 days after the start of the last cycle of treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547547
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|South Pasadena Cancer Center|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Yun I. Yen, MD||City of Hope Medical Center|