Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors
A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
調査の概要
詳細な説明
Primary Objectives:
I. To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.
II. To determine the safety and toxicity of this regimen in these patients. III. To determine the pharmacokinetics of this regimen in these patients.
Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 8 weeks.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
-
Duarte、California、アメリカ、91010
- City of Hope
-
Los Angeles、California、アメリカ、90033
- University of Southern California/Norris Cancer Center
-
Sacramento、California、アメリカ、95817
- University of California at Davis Cancer Center
-
-
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 confirmed malignant solid tumor
- Advanced disease, meeting both of the following criteria: Metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective.
- No known active brain metastases
- Life expectancy > 3 months
- ECOG performance status 0-2
- Bilirubin normal
- No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit study compliance.
- Negative pregnancy test
- Fertile patients must use effective contraception
- Recovered from prior therapy
- No prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C).
- No prior targeted therapy within the past 4 weeks
- No prior immunotherapy within the past 4 weeks
- No prior radiotherapy within the past 4 weeks.
- No more than 2 prior chemotherapy regimens for advanced solid tumors.
- No other concurrent investigational agents. Bisphosphonate therapy (e.g., pamidronate or zolendronate) is not considered investigational therapy.
- No concurrent antiretroviral therapy for HIV-positive patients.
- No other concurrent anticancer agents or therapies.
- Tumor has spread to other parts of the body or cannot be removed by surgery.
- More than 4 weeks since chemotherapy, biological therapy, or radiation therapy.
- No more than two previous chemotherapy regimens for advanced solid tumor.
- WBC >= 3,000/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine clearance >= 60 mL/min
- Absolute neutrophil count >= 1,500/mm³
- AST and ALT =< 2.5 times upper limit of normal
- No prior cumulative cisplatin dose > 300 mg/m^2
- No preexisting neuropathy <= grade 2
- Not pregnant or nursing
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 |
---|---|
実験的:Arm 1
Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
|
与えられた IV
他の名前:
与えられた IV
他の名前:
相関研究
他の名前:
相関研究
|
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 |
---|---|
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
時間枠:28 days
|
28 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Survival
時間枠:From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
|
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
|
From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
|
Time to failure
時間枠:Up to 8 weeks
|
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
|
Up to 8 weeks
|
協力者と研究者
捜査官
- 主任研究者:Marianna Koczywas、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (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。