FR901228 in Treating Patients With Metastatic Breast Cancer
A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in these patients.
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2.4-12.3 months.
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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Texas
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Houston、Texas、アメリカ、77030
- M D Anderson 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:
Histologically or cytologically confirmed breast cancer
- Metastatic disease
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
The following are not considered measurable disease:
- Bone disease only
- Pleural effusion
- Peritoneal effusion
Must have received prior anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant therapy or for advanced disease
- Therapy with high-dose regimens or bone marrow transplantation is considered 1 prior regimen
- No known brain metastases
Hormone receptor status:
- Not specified
- Male or female
- Performance status - ECOG 0-1
- Performance status - Karnofsky 70-100%
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- QTc < 500 msec
- No New York Heart Association class III or IV congestive heart failure
- No myocardial infarction within the past year
- No uncontrolled dysrhythmia
- No poorly controlled angina
- No other significant cardiac disease
- No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to FR901228
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No concurrent biologic agents
- No more than 1 prior chemotherapy regimen for metastatic disease
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior FR901228 (depsipeptide)
- No other concurrent chemotherapy
- Prior hormonal therapy for metastatic disease or as adjuvant therapy allowed
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- More than 2 weeks since prior minor surgery and recovered
- More than 4 weeks since prior major surgery and recovered
- Concurrent bisphosphonates allowed provided therapy was initiated ≥ 3 months ago
- No concurrent agents that cause QTc prolongation
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent drugs known to have histone deacetylase activity (e.g., valproic acid)
- No other concurrent investigational agents
- No other concurrent anticancer therapy
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:治療(ロミデプシン)
患者は、FR901228 (デプシペプチド) IV を 1、8、および 15 日目に 4 時間以上受けます。
コースは、疾患の進行や許容できない毒性がない場合、28 日ごとに繰り返されます。
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与えられた IV
他の名前:
オプションの相関研究
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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 |
---|---|
Efficacy (complete and partial response) according to RECIST
時間枠:Up to 14 months
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Up to 14 months
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Progression-free survival
時間枠:From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months
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From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Toxicity as measured by the standard WHO grading system
時間枠:Up to 14 months after completion of study treatment
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Up to 14 months after completion of study treatment
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協力者と研究者
捜査官
- 主任研究者:Massimo Cristofanilli、M.D. Anderson Cancer 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。
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