Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating patients who have advanced cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the dose-limiting toxicity and maximum tolerated dose of epirubicin and irinotecan in patients with advanced cancer.
- Determine the objective antitumor responses in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 1 hour followed by epirubicin IV over 5 minutes on days 1 and 8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of epirubicin is followed by sequential dose escalation of irinotecan. Cohorts of 3-6 patients receive escalating doses of epirubicin and irinotecan until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- Lombardi Cancer Center at Georgetown University Medical 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
DISEASE CHARACTERISTICS:
Histologically documented incurable malignancy for which there is no beneficial standard therapy
- Locally unresectable or metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 8 weeks
Hematopoietic:
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.2 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- Ejection fraction at least 50% by MUGA scan
- No congestive heart failure
Other:
- Maintaining a reasonable state of nutrition
- No frequent vomiting or severe anorexia
- No weight loss greater than 10% of current body weight within the past 4 weeks
- No other concurrent medical illness that would preclude study
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- Prior doxorubicin allowed if cumulative dose no greater than 240 mg/m2
Endocrine therapy:
- Not specified
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- Recovered from prior 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
協力者と研究者
スポンサー
捜査官
- スタディチェア:John L. Marshall, MD、Lombardi 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)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000068710
- P30CA051008 (米国 NIH グラント/契約)
- GUMC-00191
- GUMC-072000-001
- NCI-G01-1956
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。
イリノテカン塩酸塩の臨床試験
-
University of CologneServier募集
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Massachusetts General HospitalStand Up To Cancer募集