Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma
Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma
RATIONALE: Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining celecoxib with epirubicin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of epirubicin when given together with celecoxib and to see how well it works in treating patients with hepatocellular carcinoma (liver cancer).
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose of epirubicin when administered with celecoxib in patients with hepatocellular carcinoma.
- Determine the response rate in patients treated with this regimen.
- Determine the 6-month and overall survival of patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
- Determine the effects of this regimen on serum levels of vascular endothelial growth factor and correlate these effects with response in these patients.
- Correlate the expression of cyclooxygenase-2 in tumor tissue and nonmalignant liver tissue with response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of epirubicin.
- Phase I:Patients receive epirubicin IV over 20 minutes on day 1 and oral celecoxib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-5 patients receive escalating doses of epirubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 5 patients experience dose-limiting toxicity.
- Phase II: Additional patients are accrued and treated as in phase I at the MTD of epirubicin.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-52 patients (3-15 for phase I and 12-37 for phase II) will be accrued for this study.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60611
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
-
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:
Diagnosis of localized or metastatic hepatocellular carcinoma (HCC) by 1 of the following:
- Biopsy
- Alpha-fetoprotein (AFP) measurement (greater than 400 ng/mL if hepatitis B surface antigen [HBsAg] is negative OR greater than 1,000 ng/mL if HBsAg is positive)
- Not amenable to surgical resection or liver-directed therapy
- Measurable or evaluable disease* NOTE: *Changes in AFP alone are not sufficient
- Child-Pugh score A or B
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 75,000/mm^3
Hepatic
- Bilirubin no greater than 3.0 mg/dL
- AST no greater than 5 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- LVEF greater than 45% by MUGA or echocardiogram
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) except low-dose (81 mg) aspirin
- No known hypersensitivity to aspirin or other NSAIDs
- No contraindication to cyclooxygenase-2 (COX-2) inhibitor therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior therapy for HCC
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
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 |
|---|
|
回答率
|
|
全生存
|
|
6ヶ月生存
|
|
Maximum tolerated dose of epirubicin
|
二次結果の測定
結果測定 |
|---|
|
毒性プロファイル
|
|
Serum vascular endothelial growth factor levels in correlation to response
|
|
Cyclooxygenase-2 expression in tumor tissue and nonmalignant liver tissue in correlation to response
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Mary Mulcahy, MD、Robert H. Lurie Cancer 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
追加の関連 MeSH 用語
その他の研究ID番号
- NU 02I6
- NU-02I6
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
肝臓がんの臨床試験
-
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