PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.
In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.
調査の概要
詳細な説明
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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Arizona
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Scottsdale、Arizona、アメリカ、85259
- Scottsdale Healthcare
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Tucson、Arizona、アメリカ、85724
- University of Arizona/Arizona Cancer Center
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California
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Beverly Hills、California、アメリカ、90211-18500
- Tower Hematology Oncology Medical Group
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Maryland
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Baltimore、Maryland、アメリカ、21231
- Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
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Minnesota
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Minneapolis、Minnesota、アメリカ、55407
- Virginia Piper Cancer Institute/Abbott Northwestern Hospital
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- Sarah Cannon Research Institute
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Texas
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San Antonio、Texas、アメリカ、78229
- South Texas Oncology and Hematology
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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 > 18
- Zubrod performance status of 0 - 2
- Histological or cytological diagnosis of pancreatic adenocarcinoma
- Measurable or evaluable disease determined as per RECIST criteria
- Life expectancy > 12 weeks
- Written informed consent
- Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.
Exclusion Criteria:
- Islet cell or neuroendocrine carcinomas of the pancreas.
- History or presence of central nervous system disease.
- Patients with a history of another primary malignancy < 5 years
- Prior chemo therapy < 21 days prior to registration.
- Prior biologic or immunotherapy < 14 days prior to registration
- Prior full field radiotherapy < 28 days or limited field radiotherapy < 14 days prior to registration.
- Major surgery < 28 days prior to registration.
- Patients who have received investigational drugs < 28 days prior to registration.
- Prior therapy with anti-VEGF agents.
- Pleural effusion or ascites that causes respiratory compromise.
- Female patients who are pregnant or breast feeding.
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：なし
- 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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アクティブコンパレータ：Vatalanib
Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
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One arm: administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
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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To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
時間枠：DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives. Safety Issue: the only endpoint/outcome measure that was a safety issue was the second one (safety and tolerability of PTK) |
DSMC Schedule
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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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To assess the response rates of patients treated with PTK787/ZK222584.
時間枠：DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
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DSMC Schedule
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To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.
時間枠：DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
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DSMC Schedule
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To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.
時間枠：DSMC Schedule
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The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives.
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DSMC Schedule
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協力者と研究者
捜査官
- 主任研究者：Tomislav Dragovich, MD, PhD、University of Arizona/Arizona Cancer Center
出版物と役立つリンク
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
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。
PTK787/ZK222584の臨床試験
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David Rizzieri, MDNovartis Pharmaceuticals終了しました
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)完了
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Novartis Pharmaceuticals完了
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Beth Israel Deaconess Medical CenterRambam Health Care Campus; Dana-Farber Cancer Institute; United States Department of Defense; Brigham... と他の協力者積極的、募集していない