切除不能または転移性軟部肉腫におけるパリフォスファミド トリスとドキソルビシンとドキソルビシンの研究 (PICASSO)
切除不能または転移性軟部肉腫を有する被験者におけるパリフォスファミド トリスとドキソルビシンとドキソルビシンの第 II 相多施設共同、並行群ランダム化試験
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
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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Santa Monica、California、アメリカ
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District of Columbia
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Washington D.C.、District of Columbia、アメリカ
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Florida
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Tampa、Florida、アメリカ
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Idaho
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Coeur d'Alene、Idaho、アメリカ、83814
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Illinois
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Chicago、Illinois、アメリカ
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Park Ridge、Illinois、アメリカ
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Iowa
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Iowa City、Iowa、アメリカ
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Kansas
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Lenexa、Kansas、アメリカ
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New Mexico
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Albuquerque、New Mexico、アメリカ
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New York
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New York、New York、アメリカ
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North Carolina
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Durham、North Carolina、アメリカ
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Oregon
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Portland、Oregon、アメリカ
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ
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Tennessee
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Memphis、Tennessee、アメリカ
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Nashville、Tennessee、アメリカ
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Texas
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San Antonio、Texas、アメリカ
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Utah
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Salt Lake City、Utah、アメリカ
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Washington
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Seattle、Washington、アメリカ
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Milan、イタリア
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Padova、イタリア
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Torino、イタリア
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Cluj-Napoca、ルーマニア、400015
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Lasi、ルーマニア
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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:
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Age ≥18 years
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Histological or cytological documentation of sarcoma (excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for whom treatment with doxorubicin is considered medically acceptable. Prior treatment with IFOS is acceptable.
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Have measurable disease as per RECIST criteria (Appendix 2)
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ECOG Performance Status of 0 or 1 (Appendix 3)
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Anthracyclin naïve
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Life expectancy of ≥12 weeks
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Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelet count 100,000/mm3
- Total bilirubin ≤1.5×ULN (upper limit of normal)
- ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease
- Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT] <1.5×ULN (≤2.0×ULN for subjects on anticoagulation prophylactic regimen). Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate.
- Serum creatinine ≤ULN
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Written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
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Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial
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Women of childbearing potential must have a urine pregnancy test performed within 14 days of the start of treatment
Exclusion Criteria:
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Has any one of the following sarcoma sub types: alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma.
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Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4)
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Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V (Appendix 4)
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History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
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Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45%
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History of HIV infection
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Prior nephrectomy or history of urinary tract obstruction
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Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
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Any major surgery within 3 weeks prior to start of treatment
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Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
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Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies curatively treated >5 years prior to entry)
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Pregnancy or lactation
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Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
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Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements
In addition, use of the following therapies and medications-prior or concomitant-would exclude a subject from this study:
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Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during the study or within 4 weeks of study entry (6 weeks for Mitomycin C)
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Prior treatment with doxorubicin
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Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1)
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Bone marrow transplant or stem cell rescue within 4 months of study entry
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Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or biological response modifiers within 3 weeks of study entry
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：Palifosfamide-Tris Plus Doxorubicin
Participants received palifosfamide-tris 150 mg/m² IV on Days 1, 2, and 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Doxorubicin was administered approximately 60 minutes after completion of the Day 1 palifosfamide-tris infusion. Participants could continue single-agent palifosfamide-tris after completion of combination treatment. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
他の名前：
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
他の名前：
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アクティブコンパレータ：Doxorubicin Alone With Optional Palifosfamide-Tris After Progression
Participants received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants whose disease progressed at or before Cycle 6 could elect to receive single-agent palifosfamide-tris after disease progression. This treatment was optional and was not part of the randomized initial treatment assignment. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
他の名前：
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
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 |
時間枠 |
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一次有効性分析は、治療意図 (ITT) 集団に対して実施されます。疾患が進行するか、プロトコール外の抗がん療法が開始されるまで、6 週間ごとに疾患状態の評価を実施するためのあらゆる試みが行われます。
時間枠：進行するまで6週間ごと
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進行するまで6週間ごと
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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：Jonathan J Lewis, MD, PhD、ZIOPHARM Oncology, Inc
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 (推定)
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
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。