High-Selenium Brassica Juncea, Irinotecan, and Capecitabine in Treating Patients With Advanced Cancer
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 10/31/2015 |
| Първо изпратено: | 10/18/2007 |
| Очаквано записване подадено: | 10/18/2007 |
| Първо публикувано: | 10/21/2007 |
| Изпратена последна актуализация: | 11/03/2015 |
| Последна актуализация публикувана: | 11/05/2015 |
| Действителна начална дата на проучването: | 03/31/2006 |
| Приблизителна дата на първично завършване: | 07/31/2012 |
| Очаквана дата на завършване на проучването: | 07/31/2012 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Treatment (high-selenium therapy and chemotherapy)
Drug: Treatment (high-selenium therapy and chemotherapy)
Drug: Treatment (high-selenium therapy and chemotherapy)
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Treatment (high-selenium therapy and chemotherapy) | Dietary Supplement: Treatment (high-selenium therapy and chemotherapy) 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. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine [After two 21 day cycles of treatment]
2. Toxicity [After two 21 day cycles of treatment]
3. Pharmacokinetics [For patients treated at the MTD only at the end of cycle one of treatment]
Вторични изходни мерки
1. Serum selenium and protein profile [21 days after the start of the last cycle of treatment]
