Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel.
- Determine tumor response and time to progression in this patient population treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Assess the pharmacokinetics of docetaxel in patients treated with this regimen.
OUTLINE: Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
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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Arizona
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Scottsdale、Arizona、アメリカ、85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic
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Georgia
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Atlanta、Georgia、アメリカ、30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu、Hawaii、アメリカ、96813
- MBCCOP - Hawaii
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Illinois
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Peoria、Illinois、アメリカ、61602
- CCOP - Illinois Oncology Research Association
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Urbana、Illinois、アメリカ、61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids、Iowa、アメリカ、52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines、Iowa、アメリカ、50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City、Iowa、アメリカ、51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita、Kansas、アメリカ、67214-3882
- CCOP - Wichita
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Minnesota
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Duluth、Minnesota、アメリカ、55805
- CCOP - Duluth
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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North Dakota
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Bismarck、North Dakota、アメリカ、58501-5505
- Medcenter One Health System
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Ohio
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Toledo、Ohio、アメリカ、43623-3456
- CCOP - Toledo Community Hospital
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Pennsylvania
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Danville、Pennsylvania、アメリカ、17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Sioux Falls、South Dakota、アメリカ、57104
- CCOP - Sioux Community Cancer Consortium
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Saskatchewan
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Regina、Saskatchewan、カナダ、S4T 7T1
- Allan Blair Cancer Centre
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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 unresectable or metastatic hepatocellular carcinoma not amenable to combined radiotherapy and chemotherapy or orthotopic liver transplantation
- Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm
- Evidence of disease progression by serial imaging or biochemical evidence of a rising alpha-fetoprotein by serial testing
No history of brain or other CNS metastases not amenable to local therapy
- Locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery) allowed if no evidence of CNS progression for at least 4 weeks after completion of therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Other
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80
- No grade 2 or greater peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior biologic therapy or immunotherapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- Prior chemotherapy (excluding gemcitabine) for radiosensitization allowed
- At least 4 weeks since prior chemotherapy
- At least 6 months since prior chemoembolization
- No prior chemotherapy for metastatic disease
- No other concurrent chemotherapy
Endocrine therapy
- At least 4 weeks since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to 25% or more of bone marrow
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
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：docetaxel + gemcitabine
Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. |
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 |
|---|---|
|
six-month overall survival
時間枠：at 6 months
|
at 6 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
進行までの時間
時間枠：5年まで
|
5年まで
|
|
tumor response
時間枠：Up to 5 years
|
Up to 5 years
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Alberts SR, Reid JM, Morlan BW, Farr GH Jr, Camoriano JK, Johnson DB, Enger JR, Seay TE, Kim GP. Gemcitabine and docetaxel for hepatocellular carcinoma: a phase II North Central Cancer Treatment Group clinical trial. Am J Clin Oncol. 2012 Oct;35(5):418-23. doi: 10.1097/COC.0b013e318219863b.
- Kim GP, Alberts SR, Tschetter LK, et al.: Gemcitabine and docetaxel in patients with measurable unresectable or metastatic hepatocellular carcinoma (HCC), a North Central Cancer Treatment Group (NCCTG) phase II trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4270, 380s, 2004.
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
- NCCTG-N0041
- NCI-2012-02349 (レジストリ識別子：CTRP (Clinical Trials Reporting System))
- CDR0000068019 (レジストリ識別子：PDQ (Physician Data Query))
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