Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy.
- Compare the toxicity of these regimens in these patients.
- Compare the response rate, time to progression, and survival of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses.
- Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses.
Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II.
PROJECTED ACCRUAL: A total of 200 patients 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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Bari、イタリア、70126
- Istituto Di Ricovero E Cura A Carattere Scientifico
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Benevento、イタリア、82100
- Azienda Ospedaliena G. Rummo
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Campobasso、イタリア
- Ospedale Cardarelli - Campobasso
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Cosenza、イタリア、87100
- Ospedale Civile Cosenza
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Milan、イタリア、20157
- Ospedale Luigi Sacco
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Milan、イタリア、20153
- Ospedale San Giuseppe
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Milano、イタリア、20142
- Ospedale San Paolo
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Naples、イタリア、80131
- Federico II University Medical School
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Naples、イタリア、80131
- Istituto Nazionale per lo Studio e la Cura dei Tumori
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Naples、イタリア、80131
- Ospedale Vincenzo Monaldi
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Naples、イタリア、80133
- Seconda Universita di Napoli
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Noale、イタリア
- Ospedale Civile P.F. Calvi
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Palermo、イタリア
- Ospedale La Maddalena - Palermo
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Palermo、イタリア、90127
- Azienda Ospedaliera Policlinico Paolo Giaccone
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Potenza、イタリア、85100
- Ospedale San Carlo
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Salerno、イタリア
- Ospedale da Procida
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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 or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
- Metastatic supraclavicular lymphadenopathy or malignant pleural effusion
- Progressive disease
- Must have received prior chemotherapy
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN
Renal:
- Creatinine no greater than 1.25 times ULN
Cardiovascular:
- No prior or concurrent cardiovascular disease that would preclude study
Pulmonary:
- See Disease Characteristics
- No prior or concurrent pulmonary disease that would preclude study
Other:
- No prior or other concurrent illness or medical condition that would preclude study
- No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior docetaxel
- At least 3 weeks since other prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy allowed
- No concurrent radiotherapy
Surgery:
- Prior radical surgery for NSCLC allowed
- Concurrent palliative surgery allowed
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
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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毒性
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進行までの時間
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回答率
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生活の質
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サバイバル
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協力者と研究者
捜査官
- スタディチェア：Cesare Gridelli, MD、Istituto Nazionale per lo Studio e la Cura dei Tumori
出版物と役立つリンク
一般刊行物
- Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2007 Apr 10;25(11):1377-82. doi: 10.1200/JCO.2006.09.8251.
- Gridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer. 2004 Dec 13;91(12):1996-2004. doi: 10.1038/sj.bjc.6602241.
研究記録日
主要日程の研究
研究開始
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
- CDR0000068702
- ITA-INTN-DISTAL
- EU-20103
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