Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy
For patients relapsing after platinum-based therapy, few data are available. The current use of cetuximab associated with radiotherapy in localized disease and associated with platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based on a clinical review, show encouraging antitumour activity and an acceptable safety profile. Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen after platinum failure.
The present study has been designed as a multicenter, randomised phase III study which will compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN patients having failed platinum-based therapy.
調査の概要
詳細な説明
This study was designed to compare the OS of VFL plus MTX versus MTX alone in patients with SCCHN who had failed platinum-based chemotherapy.
The trial was designed in accordance with current standards used routinely in oncology phase III trials and used established methods of assessment. The RECIST (version 1.1) and NCI CTCAE (version 3.0) guidelines are internationally recognised methods for assessing efficacy and tolerance, respectively.
The patient population was appropriate for this type of phase III study and included adult patients with recurrent and/or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, who had received prior chemotherapy regimens with documented progression. This population of patients was considered appropriate to meet the study objectives.
Recent preliminary phase I results of the VFL plus MTX combination in SCCHN, reported in a clinical review, showed encouraging antitumour activity and an acceptable safety profile A number of chemotherapy agents have been reported as having single-agent activity in SCCHN. However, reliable evidence of efficacy in the second-line setting is lacking, and there is currently no established standard of care. MTX used alone as the reference regimen at a dose of 40 mg/m2/week can be considered as the best available evidence-based option. Also, other trials using this comparator have demonstrated that it is generally accepted as a reasonable choice, and is often used in general practice.
The efficacy and safety assessments employed in this study are standard measures routinely used in studies of this type
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Toulouse、フランス
- Institut de Recherche Pierre Fabre
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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:
- Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma
- Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative
- Measurable or non measurable disease
- adequate haematological, hepatic and renal functions
- WHO performance status < 1
Exclusion Criteria:
- Nasopharyngeal carcinoma
- History of brain or leptomeningeal involvement
- Albumin level < 35 g/L
- Patients with weight loss ≥ 5% within the last 3 months
- Grade > 2 peripheral neuropathy at study entry
- "Third space" fluids (pleural effusion, ascites, massive edema)
- Prior treatment with vinca-alkaloids and methotrexate
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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実験的：Vinflunine plus methotrexate
vinflunine IV 280 mg/m² Day 1 plus methotrexate IV 30 mg/m² Day 1 and Day 8 every 3 weeks
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他の名前：
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アクティブコンパレータ：Methotrexate
methotrexate IV 40 mg/m² Day 1, 8 and 15 every 3 weeks
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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 |
|---|---|---|
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Overall Survival in the ITT Population (Months)
時間枠：Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months
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Time from randomization to the date of death or last follow-up.
The survival duration of patients still alive, was censored at the date of last contact or last follow-up.
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Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months
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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 |
|---|---|---|
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Progression Free Survival
時間枠：an expected average of 4 months
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Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)
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an expected average of 4 months
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Objective Response Rate (ORR)
時間枠：6 weeks
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The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.
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6 weeks
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Disease Control Rate
時間枠：30 months
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Percentage of best overall responses CR, PR and SD in the analysed population
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30 months
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Duration of Response
時間枠：30 months
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Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.
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30 months
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Zahida Issiakhem, MD、Institut de Recherche Pierre Fabre
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
- L00070 IN 309 F0
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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