NCT00547547

High-Selenium Brassica Juncea, Irinotecan, and Capecitabine in Treating Patients With Advanced Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2007-10-22
• Last updated: 2015-11-06

Locations

2 sites across 1 country: United States