Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck
Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck
This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of this combination of medications for this type of cancer.
Approximately 54 subjects will take part in this study.
調査の概要
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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California
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Los Angeles、California、アメリカ、90033
- USC/Norris Comprehensive Cancer Center
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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:
- Patients must have histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection. If it is not available, a repeat biopsy must be performed.
- Age greater than or equal to 18 years
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 50%)
- Patients must have adequate organ and marrow function as defined below:
- leukocytes greater than or equal to 3,000/microliter
- hemoglobin greater than or equal to 8.0 g/dl
- absolute neutrophil count greater than or equal to 1,500/microliter
- platelets greater than or equal to 100,000/microliter
- total bilirubin within normal institutional limits
- creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
If:
- ALK PHOS is less than or equal to ULN and AST or ALT is less than or equal to ULN, patient is eligible.
- ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
- ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is eligible.
- ALK PHOS is less than or equal to ULN and AST or ALT is greater than 5x ULN, patient is ineligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is less than or equal to ULN, patient is eligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 5x ULN, patient is ineligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is less than or equal to ULN,patient is eligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1x but less than or equal to 1.5x, patient is ineligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1.5x but less than or equal to 5x, patient is ineligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 5x ULN, patient is ineligible.
- ALK PHOS is greater than 5x ULN and AST or ALT is less than or equal to ULN, patient is ineligible.
- ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is ineligible
- ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible
- ALK PHOS is greater than 5x ULN and AST or ALT is greater than 5x ULN, patient is ineligible
- Patients with neuropathy < 1.
- Ability to understand and the willingness to sign a written informed consent document
- Women of childbearing potential must have a negative pregnancy test
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Patients undergoing therapy with other investigational agents.
- Previous treatment involving regimen utilizing any of the protocol chemotherapeutic agents
- Patients with known brain metastases
- History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. Patients with a history of severe hypersensitivity reaction to Taxotere or Oxaliplatin or other drugs formulated with polysorbate 80
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia
- Pregnant and nursing women
- HIV-positive patients
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:非ランダム化
- 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 |
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実験的:Arm 1
On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2.
Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min.
This treatment regimen will be repeated every 21 days.
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Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min.
on day 1 every 3 weeks.
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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 |
---|---|---|
Tumor Response
時間枠:6 months after the last subject enrolled has gone off study
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All eligible patients who received the first dose of Taxotere will be included in the analysis. Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease. Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
6 months after the last subject enrolled has gone off study
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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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Number of Participants With Serious Adverse Events (SAEs)
時間枠:At end of every cycle
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Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
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At end of every cycle
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協力者と研究者
協力者
捜査官
- 主任研究者:Barbara Gitlitz, MD、University of Southern California
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
- 7H-03-1
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。
Taxotereの臨床試験
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Shandong Cancer Hospital and Instituteわからない
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Shanghai Jiao Tong University School of MedicineFudan University; Qilu Hospital of Shandong University募集
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Sanofi完了前立腺腫瘍アメリカ, フランス, ブラジル, ロシア連邦, オーストラリア, 七面鳥, インド, オーストリア, イスラエル, イタリア, メキシコ, イギリス, ドイツ, ポーランド, オランダ, 南アフリカ, カナダ
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Dana-Farber Cancer InstituteBeth Israel Deaconess Medical Center; Genentech, Inc.; Brigham and Women's Hospital完了
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pharmaand GmbHFoundation Medicine積極的、募集していない転移性去勢抵抗性前立腺がんアメリカ, カナダ, スペイン, フランス, オーストラリア, アイルランド, ベルギー, デンマーク, イギリス, ドイツ, イスラエル, イタリア