Vinorelbine-ifosfamide Versus Gefitinib for EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients
A Phase Ⅱ Randomized Clinical Trial Comparing Vinorelbine-ifosfamide With Gefitinib as Third-line Treatment in Advanced EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients
調査の概要
詳細な説明
Ifosfamide is a first generation cytotoxic drug to treat NSCLC. Phase Ⅱ studies demonstrated that single-agent ifosfamide administrated by various schedules produces response rates of 15-29%, with media survival times of 5-7 months. Ifosfamide has also been used in various combination regimens to treat NSCLC, including platinum based and non-platinum regimens. But in refractory NSCLC patients platinum and some third generation cytotoxic drugs have been used before. So in this study, ifosfamide is combined with vinorelbine. In previous study, Masters reported the objective response rate was 40% and the median survival duration was 50 weeks, with a 1-year survival rate of 48% with vinorelbine-ifosfamide regimen [Vinorelbine 15 mg/m2 on days 1-3, and ifosfamide 2.0g/m2 on days 1-3 with granulocyte-colony stimulating factor (G-CSF) support]. The dose limiting toxicity (DLT) of this regimen is myelosuppression. In our experience, the regimen of vinorelbine 25mg/m2 d1, d8 and ifosfamide 1.25g/m2 d1-d3 with Mesna uroprotection is safe in Chinese population and the objective response rate is about 7% (data not published).
Gefitinib is the first small molecule inhibitor that has directed activity towards EGFR and has shown appreciable response rates in phase Ⅱ trials of patients with previously treated advanced NSCLC. In the posterior analysis of Iressa Dose Evaluation in Advanced Lung Cancer (IDEAL) and IRESSA Survival Evaluation in Lung Cancer (ISEL) trials, the response rate with gefitinib ranges from 2.6% to 10% in wild-type EGFR gene NSCLC patients.
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
研究連絡先
- 名前:Mengzhao Wang, MD
- 電話番号:+86 010-69155039
- メール:mengzhaowang@sina.com
研究連絡先のバックアップ
- 名前:Jing Zhao, MD
- 電話番号:+86 010-69158206
- メール:pumchzj@sina.com
研究場所
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Beijing
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Beijing、Beijing、中国、100730
- 募集
- Department of Respiratory Medicine, Peking Union Medical College Hospital
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コンタクト:
- Mengzhao Wang, MD
- 電話番号:+86 010-69155039
- メール:mengzhaowang@sina.com
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コンタクト:
- Jing Zhao, MD
- 電話番号:+86 010-69158206
- メール:pumchzj@sina.com
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副調査官:
- Wei Zhong, MD
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副調査官:
- Jinmei Luo, MD
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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:
- age range:18-70 years old
- life expectancy more than 12 weeks
- histologically or cytologically confirmed inoperable NSCLC (stage ⅢB/Ⅳ)
- ineligible for curative radiotherapy
- no prior radiotherapy for the target lesions
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2;
- prior treatments include first-line platinum doublet chemotherapy i.e. PC or GP and second-line chemotherapy with docetaxel or pemetrexed;
- No EGFR gene mutation detected by Scorpions-ARMS;
- at least one bidimensionally measurable or radiographically assessable lesion;
- adequate bone marrow reserve;
- adequate hepatic and renal function;
Exclusion Criteria:
- prior treatments including any of the following drugs:gefitinib,vinorelbine and ifosfamide;
- additional malignancies;
- uncontrolled systemic disease;
- any evidence of clinically active interstitial lung disease;
- newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery;
- pregnancy or breast feeding phase;
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
- 介入モデル:並列代入
- 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 |
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他の:Gefitinib
Gefitinib group Gefitinib (Iressa) 250mg once per day until progression disease or intolerant side effects
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Gefitinib 250mg once per day until the progression disease or intolerant side effects
他の名前:
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他の:Vinorelbine-Ifosfamide
VI group Vinorelbine 25mg/m2 d1,d8;Ifosfamide 1.25g/m2 d1-d3(Usually Ifosfamide 2g d1-d3 with Mesna 400mg 0,4,8hours after Ifosfamide administration for 3 days);every 3 weeks;at least for 2-6 cycles depending on the progression disease or the patient's physical condition
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Vinorelbine 25mg/m2 d1,d8; Ifosfamide 1.25g/m1 d1-d3 (Usually 2g d1-d3); Mesna 400mg 0,4,8 hours after Ifosfamide administration for uroprotection d1-d3;
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:up to 52 weeks (about one year)
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
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up to 52 weeks (about one year)
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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 |
---|---|---|
全生存
時間枠:最大100週間
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無作為化日から何らかの原因による死亡日まで、最大 100 週間評価されます。
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最大100週間
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objective response rate
時間枠:up to 9 weeks
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The objective response rate includes the complete remission and partial remission rate.
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up to 9 weeks
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the score of functional assessment of cancer treatment-lung (FACT-L)
時間枠:Up to 100 weeks
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FACL-L is assessed at different time points.(Date of randomization, 1 week after chemotherapy/EGFR-TKI, every cycle of chemotherapy/EGFR-TKI, every month of EGFR-TKI treatment/observation, up to 100 weeks)
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Up to 100 weeks
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Number of participants with adverse events
時間枠:Up to six months
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The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria (Version 3.0) (NCI-CTC).
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Up to six months
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協力者と研究者
捜査官
- 主任研究者:Mengzhao Wang, MD、Department of Respiratory Medicine, Peking Unoin Medical College Hospital
出版物と役立つリンク
一般刊行物
- Bell DW, Lynch TJ, Haserlat SM, Harris PL, Okimoto RA, Brannigan BW, Sgroi DC, Muir B, Riemenschneider MJ, Iacona RB, Krebs AD, Johnson DH, Giaccone G, Herbst RS, Manegold C, Fukuoka M, Kris MG, Baselga J, Ochs JS, Haber DA. Epidermal growth factor receptor mutations and gene amplification in non-small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol. 2005 Nov 1;23(31):8081-92. doi: 10.1200/JCO.2005.02.7078. Epub 2005 Oct 3.
- Hirsch FR, Varella-Garcia M, Bunn PA Jr, Franklin WA, Dziadziuszko R, Thatcher N, Chang A, Parikh P, Pereira JR, Ciuleanu T, von Pawel J, Watkins C, Flannery A, Ellison G, Donald E, Knight L, Parums D, Botwood N, Holloway B. Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5034-42. doi: 10.1200/JCO.2006.06.3958.
- Thatcher N, Anderson H, Smith DB, Steward WP, Webb K, Hilton A, Rahman A. Ifosfamide by bolus as treatment for advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 1986;18 Suppl 2:S30-3. doi: 10.1007/BF00647448.
- Holoye PY, Glisson BS, Lee JS, Dhingra HM, Murphy WK, Umsawasdi T, Levy JK, Jeffries D, Raber MN, Hong WK. Ifosfamide with mesna uroprotection in the management of lung cancer. Am J Clin Oncol. 1990 Apr;13(2):148-55. doi: 10.1097/00000421-199004000-00012.
- Masters GA, Hoffman PC, Hsieh A, Drinkard LC, Mick R, Samuels BL, Guaspari A, Golomb HM, Vokes EE. Phase I study of vinorelbine and ifosfamide in advanced non-small-cell lung cancer. J Clin Oncol. 1997 Mar;15(3):884-92. doi: 10.1200/JCO.1997.15.3.884.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
非小細胞肺がんの臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
Gefitinib groupの臨床試験
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University Hospital, GhentUniversity Ghent募集
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Centre hospitalier de l'Université de Montréal...University Health Network, Toronto; University of British Columbia; McGill University; University... と他の協力者募集
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Sichuan Provincial People's Hospitalわからない
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完了
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Northeast Center for Rehabilitation and Brain InjuryProbed Medical USAわからない