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

NCT00547547 | Completed Phase 1 DMC

• 4 other identifiers: 05122P30CA033572CHNMC-05122CDR0000570284
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine

  After two 21 day cycles of treatment

• Toxicity

  After two 21 day cycles of treatment

• Pharmacokinetics

  For patients treated at the MTD only at the end of cycle one of treatment

Secondary Outcomes (1)

• Serum selenium and protein profile

  21 days after the start of the last cycle of treatment

Study Arms (1)

Treatment (high-selenium therapy and chemotherapy)

EXPERIMENTAL

Dietary Supplement: high-selenium Brassica juncea; Drug: capecitabine; Drug: irinotecan hydrochloride

Interventions

high-selenium Brassica juncea DIETARY_SUPPLEMENT

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.

Treatment (high-selenium therapy and chemotherapy)

capecitabine DRUG

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.

Treatment (high-selenium therapy and chemotherapy)

irinotecan hydrochloride DRUG

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.

Treatment (high-selenium therapy and chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

South Pasadena Cancer Center

Pasadena, California, 91105, United States

Location

MeSH Terms

Interventions

Capecitabine; Irinotecan

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Study Officials

• Yun I. Yen, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: April 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

US (2)