Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To assess progression-free survival (PFS) measured at 16 weeks following initiation of once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular carcinoma.
SECONDARY OBJECTIVES:
I. To assess objective response rate, rate and duration of stable disease, time to progression, median and overall survival in this patient population, and any changes in tumor perfusion based on functional CT imaging.
II. To correlate response with patient characteristics including: age, disease stage (TNM, Okuda [6]), viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, Performance Status, serum values of: alpha feto-protein, bilirubin, transaminases, albumin; EGFR expression score by IHC; and development of skin rash during therapy.
III. To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient population.
IV. To determine the safety and tolerability of OSI-774 in this patient population.
OUTLINE: Patients are stratified according to epidermal growth factor receptor expression (low, 0-1+ vs high, 2-3+).
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- M D Anderson 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:
Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection
- No fibrolamellar HCC
No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents
The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study
- Surgery
- Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection)
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- Must have paraffin tissue block or unstained slides from biopsy or surgical specimen
- No known brain metastases
- No ascites that are refractory to conservative management (e.g., sodium restriction to 50 mEq/day dietary sodium and fluid restrictions and/or diuretics)
- Performance status - ECOG 0-2
- At least 16 weeks
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 60,000/mm^3
- Hemoglobin at least 10 g/dL
- Bilirubin no greater than 1.8 mg/dL
- Albumin at least 2.5 g/dL
- AST/ALT no greater than 5 times upper limit of normal
- PT no greater than 1-3 seconds over normal
- No decompensated liver disease
- No jaundice
- No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius)
- No hyponatremia with sodium less than 125 mEq/L
- No portal hypertension with bleeding esophageal or gastric varices within the past 3 months
- Creatinine no greater than 2 mg/dL
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation
- No active peptic ulcer disease
- No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No other uncontrolled concurrent illness that would preclude study participation
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior surgical therapy affecting absorption
- More than 30 days since prior investigational agents
- No concurrent commercial or other investigational anticancer agents or therapies
- No concurrent combination antiretroviral therapy for HIV-positive patients
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 (erlotinib hydrochloride)
Patients receive oral erlotinib once daily.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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相関研究
相関研究
他の名前:
与えられたPO
他の名前:
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Progression-free survival
時間枠:Time from initiation of therapy until documented disease progression, assessed at 16 weeks
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Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.
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Time from initiation of therapy until documented disease progression, assessed at 16 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Objective response rate
時間枠:Up to 4 years
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Summarized by estimates and standard errors.
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Up to 4 years
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Rate of stable disease
時間枠:Up to 4 years
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Summarized by estimates and standard errors.
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Up to 4 years
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Duration of stable disease
時間枠:From the start of the treatment until the criteria for progression are met, assessed up to 4 years
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Summarized by Kaplan-Meier curves, from which medians and overall duration of stable disease can be attained.
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From the start of the treatment until the criteria for progression are met, assessed up to 4 years
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Time to progression
時間枠:Up to 4 years
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Summarized by Kaplan-Meier curves, from which medians and time to progression can be attained.
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Up to 4 years
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Overall survival
時間枠:Up to 4 years
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Summarized by Kaplan-Meier curves, from which medians and overall survival can be attained.
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Up to 4 years
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協力者と研究者
捜査官
- 主任研究者:Melanie Thomas、M.D. Anderson Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (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
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