Temsirolimus as Second-line Therapy in HCC
A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma
調査の概要
詳細な説明
Currently, no standard therapy exists for patients who progress on sorafenib. mTOR signaling is often up-regulated in HCC promoting cell growth and survival. This process is inhibited by rapamycin, a specific inhibitor of mTOR. Temsirolimus, a rapamycin analog, may delay tumor progression by inhibiting mTOR in HCC.Intervention: Temsirolimus IV
Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Tennessee
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Memphis、Tennessee、アメリカ、38120
- 募集
- Boston Baskin Cancer Foundation
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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 must have advanced unresectable or metastatic hepatocellular carcinoma (HCC). Prior diagnosis of HCC could have been established histologically or based on one of the following criteria:
- Liver mass > 2cm: Characteristic enhancement on at least one imaging technique(triphasic CT scan, MRI, or contrast enhanced ultrasound) or AFP > 200 ng/ml.
- Liver mass between 1 and 2 cm: Characteristic enhancement on two imaging techniques.Diagnosis of HCC must have been confirmed by biopsy if non-characteristic enhancement on imaging.
- All patients must have received exactly one prior systemic therapy (cytotoxic chemotherapy or targeted therapies) and must not be eligible for further locoregional treatment modalities.
- All patients must have measurable disease per RECIST criteria.
- Patients with previous locoregional therapies, including but not limited to radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization, and hepatic artery infused FUDR, stereotactic radiotherapy are eligible provided they have documented progression of their disease or have measurable extrahepatic disease.
- Patients must have an ECOG performance status of 0 - 2 (see Appendix B).
- Patients must be greater than or equal to 18 years of age.
- Patients with Child-Pugh class A (score of 5-6) or class B (score of 7-9) are eligible.
Patients must have adequate organ function as defined by:
- AST, ALT and Alkaline phosphatase ≤ 5x upper limit of normal (ULN)
- Total Bilirubin < 2 mg/dl.
- Creatinine clearance ≥ 15ml/min & patients must not be dialysis dependent.
Patients must have adequate bone marrow function as defined by:
- Leukocytes ≥ 2000 / mm3 or absolute neutrophil count (ANC) ≥ 1000 / mm3
- Platelet count ≥ 75000 / mm3
- Pregnant and nursing women will be excluded from this study. All patients of reproductive potential must agree to use adequate birth control measures to be eligible for study enrollment.
- Prior palliative radiotherapy is permissible provided it has been completed at least 2 weeks prior to study entry and the patient has recovered from any radiation-related side effects.
- Patients must not be receiving any other investigational agents or other anti-cancer therapies. At least 28 days must have elapsed since completion of previous systemic therapy prior to study entry and the patient should have recovered from all toxicities related to prior therapy.
- Patients must not have a history of other malignancies that are active and require therapy (other than non-melanoma skin cancers).
Exclusion Criteria:
- Patients with prior treatment with any mTOR inhibitor are not eligible.
- Patients with a history of an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
- Patients taking cytochrome P450 enzyme-inducers or inhibitors are not eligible.
- Patients with a known history of HIV infection are not eligible.
- Patients with uncontrolled hyperlipidemia or hypercholesterolemia are not eligible (fasting serum cholesterol > 350 mg/dL or fasting serum triglycerides > 400 mg/dL).
- Patients with a known history or clinical evidence of CNS metastases are not eligible.
- Patients who, in the best judgment of the investigator, will not be able to comply with the requirements of the protocol are not eligible.
Patients with Child-Pugh class C liver disease are not eligible.
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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)
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 |
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Disease Progression
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The primary outcome measure is to determine the proportion of patients who are progression free at 3 months.
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二次結果の測定
結果測定 |
メジャーの説明 |
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Response rate
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Response rate, clinical benefit rate (complete + partial response + stable disease > 12 weeks) and overall survival with temsirolimus
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Safety and tolerability
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Number and frequency of adverse events and serious adverse events will be monitored.
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Biochemical response
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Biochemical response (>50% decline in AFP levels from baseline) with temsirolimus
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Pharmacokinetics
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Pharmacokinetics will be assessed: AUC pre-dose, 1, 3, 24,48, 72 and 162 hours post dose.
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Circulating tumor cells levels
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Feasibility and utility of circulating tumor cells in this patient population
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協力者と研究者
捜査官
- 主任研究者:Jasgit Sachdev, MD、University of Tennessee Cancer Institute
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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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