3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine) and cisplatin.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. Determine the duration of response and overall survival of patients treated with this regimen.
III. Determine the palliative benefits with regard to dysphagia in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 20 months.
研究の種類
入学 (予想される)
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、60637-1470
- University of Chicago Comprehensive 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 adenocarcinoma of the esophagus or gastroesophageal junction
- Metastatic or recurrent disease
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Outside prior irradiation port
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100%
- More than 6 months
- Absolute neutrophil count ≥ 1,500/mm^3
- WBC ≥ 3,000/mm ^3
- Platelet count ≥ 100,000/mm^3
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin normal
- Creatine normal
- Creatinine clearance ≥ 50 mL/min
- No prior myocardial infarction
- No unstable angina
- No cardiac arrhythmia
- No uncontrolled congestive heart failure
- No pulmonary disease requiring supplemental oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin)
- No other concurrent uncontrolled illness
- No active or ongoing infection
- No active second malignancy
- No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents
- No psychiatric illness or social situation that would preclude study compliance
- At least 1 year since prior platinum-derivative agents
- No prior chemotherapy for metastatic or recurrent esophageal cancer
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy and recovered
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
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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実験的:Treatment (triapine and cisplatin)
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4.
Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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与えられた IV
与えられた IV
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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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Complete response rate
時間枠:Up to 2 years
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Will be calculated together with 95% confidence intervals based on the binomial distribution.
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Up to 2 years
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Objective response rate (CR + PR)
時間枠:Up to 2 years
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Will be calculated together with 95% confidence intervals based on the binomial distribution.
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Up to 2 years
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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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全生存
時間枠:2年まで
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Kaplan-Meier 推定値が決定されます。
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2年まで
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Progression-free survival
時間枠:From the start of treatment to progression or death, assessed up to 2 years
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Kaplan-Meier estimates will be determined.
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From the start of treatment to progression or death, assessed up to 2 years
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Duration of response
時間枠:From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
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From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
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Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
時間枠:Up to 2 years
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Up to 2 years
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Number of patients with improvement of dysphagia
時間枠:Up to 2 years
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Up to 2 years
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Duration of improvement of dysphagia
時間枠:Up to 2 years
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Up to 2 years
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協力者と研究者
捜査官
- 主任研究者:Ann Mauer、University of Chicago Comprehensive 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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2012-02576 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
- N01CM62201 (米国 NIH グラント/契約)
- CDR0000352307
- UCCRC-12765A
- NCI-6285
- 12765A (その他の識別子:University of Chicago Comprehensive Cancer Center)
- 6285 (その他の識別子:CTEP)
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