Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil.
- Compare the toxicity of these regimens in these patients.
- Assess the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3, 5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.
Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Leiden、オランダ、2300 CA
- Leiden University Medical Center
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Maastricht、オランダ、6202 AZ
- Academisch Ziekenhuis Maastricht
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Nijmegen、オランダ、6500 HB
- Universitair Medisch Centrum St. Radboud - Nijmegen
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Rotterdam、オランダ、3000 CA
- University Medical Center Rotterdam at Erasmus Medical Center
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Rotterdam、オランダ、3015 GJ
- Erasmus MC - Sophia Children's Hospital
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Bratislava、スロバキア、833 10
- National Cancer Institute - Bratislava
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Kassel、ドイツ、D-34125
- Klinikum Kassel
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Aalst、ベルギー、B-9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Brussels、ベルギー、1000
- Institut Jules Bordet
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Brussels、ベルギー、1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Edegem、ベルギー、B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven、ベルギー、B-3000
- U.Z. Gasthuisberg
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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 renal cell carcinoma
- Advanced metastatic disease that requires treatment
- Measurable disease (single bone lesions not included)
- No brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 to 81
Performance status
- WHO 0-1
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No myocardial infarction within the past 6 months
- No unstable angina pectoris
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 6 months after study participation
- No other concurrent disease or prior malignancy that would preclude study treatments or comparisons
- No concurrent active infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No prior endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Prior resection of the primary tumor recommended but not required
- No prior major organ allografts
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：ランダム化
- 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 |
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サバイバル
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二次結果の測定
結果測定 |
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Time to progression as measured by RECIST criteria
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Comparison of toxicity levels (Grade III and IV)
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Comparison of quality of life before, during, after completion of study treatment
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Impact of the treatment regimens on health economics
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協力者と研究者
スポンサー
捜査官
- Martin E. Gore, MD、Royal Marsden NHS Foundation Trust
- Peter F.A. Mulders, MD, PhD、Universitair Medisch Centrum St. Radboud - Nijmegen
出版物と役立つリンク
一般刊行物
- Gore ME, Griffin CL, Hancock B, Patel PM, Pyle L, Aitchison M, James N, Oliver RT, Mardiak J, Hussain T, Sylvester R, Parmar MK, Royston P, Mulders PF. Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomised trial. Lancet. 2010 Feb 20;375(9715):641-8. doi: 10.1016/S0140-6736(09)61921-8. Epub 2010 Feb 10.
- Gore ME: Interferon-α (IFN), interleukin-2 (IL2) and 5-fluorouracil (5FU) vs IFN alone in patients with metastatic renal cell carcinoma (mRCC): results of the randomised MRC/EORTC RE04 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-5039, 2008.
研究記録日
主要日程の研究
研究開始
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
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