FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma
A Phase II Study Using FDG-PET to Investigate the Dosing Schedule and Response of Combination SGN-15 (cBR96-Doxorubicin Immunoconjugate) and Docetaxel in Patients With Stage IV or Stage IIIB Non-Small Cell Lung Carcinoma Ineligible for Combined Modality Treatment With Curative Intent
調査の概要
詳細な説明
SGN-15 is a mAb-drug immunoconjugate comprised of the chimeric anti-Lewis Y (LeY) mAb BR96, conjugated to doxorubicin. The LeY antigen is found as a glycoprotein at the cell surface on 90% of carcinomas of the lung. SGN-15 induces its antitumor effect through binding to the cell surface LeY antigen. It is then rapidly internalized with release of doxorubicin inside the cell allowing the relative sparing of tissues normally affected by non-specific chemotherapy.
The study is open to patients with good performance status (ECOG 0<=2) with stage IIIB or IV NSCLC which is not potentially curable by surgery or combined modality therapy and who have received no prior lung cancer chemotherapy for metastatic NSCLC.
Patients will be registered into one of two treatment sequences and wil receive SGN-15 and docetaxel in 4 week cycles consisting of treatment weekly for 3 weeks, followed by a week of rest.
Arm A will receive a combination os SGN-15 and docetaxel on the same day. Arm B will receive the combination of SGN-15 followed by the docetaxel 3 days later. All patients will undergo PET imaging prior to treatment and on Day 22.
Patients achieving a clinical response or stable disease as determined by physical examination and/or traditional restaging studies (using established RECIST criteria) after one 4 week cycle of therapy are eligible to receive continued cycles of SGN-15 and docetaxel on the same schedule until clinical or radiographic disease progression or toxicity occurs.
研究の種類
入学
段階
- フェーズ2
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60637
- University of Chicago
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Maryland
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Baltimore、Maryland、アメリカ、21231
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Oregon
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Portland、Oregon、アメリカ、97213
- Providence Health System, Regional Cancer Program
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Portland、Oregon、アメリカ、97227-1191
- Kaiser Permanente
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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 with pathologically confirmed stage IIIB or IV NSCLC with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent
- Patients must have an ECOG performance status of less than or equal to 2
- -Patients must have a tumor block available for documentation of LeY antigen expression by immunohistochemistry
- -FDG-PET imaging must be completed at a PET center approved by Seattle Genetics
- Patients must have adequate bone marrow and hepatic function
Exclusion Criteria:
- -Prior cytotoxic therapy for metastatic NSCLC
- -Those with serious underlying non-malignant disease
- -Patients with peripheral neuropathy > Grade 2 are excluded from study
- -Patients with IDDM or NIDDM
- Patients with known active viral, bacterial, or symptomatic fungal infection
- Concomitant with other antineoplastic or experimental agents
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）
協力者と研究者
スポンサー
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
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。