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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00547547
First received: October 19, 2007
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: high-selenium Brassica juncea
Drug: capecitabine
Drug: irinotecan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine [ Time Frame: After two 21 day cycles of treatment ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: After two 21 day cycles of treatment ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: For patients treated at the MTD only at the end of cycle one of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum selenium and protein profile [ Time Frame: 21 days after the start of the last cycle of treatment ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: April 2006
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547547

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010-3000
South Pasadena Cancer Center
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Yun I. Yen, MD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00547547     History of Changes
Other Study ID Numbers: 05122, P30CA033572, CHNMC-05122, CDR0000570284
Study First Received: October 19, 2007
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Selenium
Irinotecan
Camptothecin
Capecitabine
Fluorouracil
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 11, 2014