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
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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-
California
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Duarte、California、アメリカ、91010-3000
- City of Hope Medical Center
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Pasadena、California、アメリカ、91105
- South Pasadena Cancer Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
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.
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine
時間枠：After two 21 day cycles of treatment
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After two 21 day cycles of treatment
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Toxicity
時間枠：After two 21 day cycles of treatment
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After two 21 day cycles of treatment
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Pharmacokinetics
時間枠：For patients treated at the MTD only at the end of cycle one of treatment
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For patients treated at the MTD only at the end of cycle one of treatment
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Serum selenium and protein profile
時間枠：21 days after the start of the last cycle of treatment
|
21 days after the start of the last cycle of treatment
|
協力者と研究者
捜査官
- 主任研究者：Yun I. Yen, MD、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 05122
- P30CA033572 (米国 NIH グラント/契約)
- CHNMC-05122
- CDR0000570284 (レジストリ識別子：NCI PDQ)
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