Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors
A Phase I & Pharmacologic Trial Of Sequential Irinotecan As A 24-Hour IV Infusion, Leucovorin, & Flurouracil As A 48-Hour IV Infusion In Adult Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the recommended phase II dose of irinotecan, leucovorin calcium, and fluorouracil in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetic and pharmacodynamic profiles of irinotecan and fluorouracil in patients treated with this regimen.
- Determine the correlation of polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity and response in patients treated with this regimen.
- Determine the correlation of polymorphisms in the uridine diphosphate glucuronosyltransferase 1A1 gene promoter with the extent of SN-38 glucuronidation and severity of diarrhea in patients treated with this regimen.
- Assess any anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of irinotecan and fluorouracil.
Patients receive irinotecan IV continuously over 24 hours on days 1 and 15 and leucovorin calcium IV over 30 minutes followed by fluorouracil IV continuously over 48 hours on days 2 and 16. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. Once the MTD of irinotecan has been determined, additional cohorts receive escalating doses of fluorouracil until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 20 months.
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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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
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor that has failed standard therapy or for which no standard therapy exists
- Locally advanced, unresectable, primary or recurrent disease OR
- Metastatic disease
- Previously untreated disease allowed provided this regimen represents reasonable first-line therapy
- No leukemia or lymphoma
- No primary CNS malignancy or CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.6 mg/dL
- AST/ALT no greater than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other serious concurrent illness that would preclude study
- No active infection requiring IV antibiotics
- No known hypersensitivity to irinotecan
- No marked intolerance to fluorouracil
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 4 weeks since prior immunotherapy and recovered
Chemotherapy:
- More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered
- Prior short-infusion irinotecan allowed
- Prior fluorouracil allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 2 weeks since prior radiotherapy and recovered
- At least 8 weeks since prior strontium chloride Sr 89
Surgery:
- Recovered from prior surgery
Other:
- No concurrent cimetidine
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
協力者と研究者
捜査官
- スタディチェア：Eva Szabo, MD、National Cancer Institute (NCI)
研究記録日
主要日程の研究
研究開始
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
- CDR0000068548
- NCI-01-C-0082
- MB-NAVY-00-02
- MB-NAVY-B00-038
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