Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors
調査の概要
詳細な説明
OBJECTIVES:
I. Determine the maximum tolerated dose, recommended phase II dose, and associated toxic effects of the triple combination of continuous infusion fluorouracil, weekly gemcitabine, and oxaliplatin in patients with metastatic or unresectable solid tumors.
II. Define sequence dependent toxic effects, if any, and establish pharmacokinetic and pharmacodynamic relationships in context of this triple combination chemotherapy in this patient population.
OUTLINE: This is a dose-escalation study of oxaliplatin and gemcitabine.
For course 1, and then course 3 and beyond, patients receive oxaliplatin IV over 2 hours on day 1, followed by gemcitabine IV over 30 minutes on days 1 and 8, and then fluorouracil IV continuously on days 1-14. For course 2, patients receive treatment in the same manner as in course 1, except gemcitabine is given initially, followed by oxaliplatin, and then fluorouracil. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPTD) is defined as the dose preceding MTD.
Once RPTD is defined, the cohort is expanded to an additional 13 patients. These patients receive a fixed dose of oxaliplatin, gemcitabine, and fluorouracil as determined by the phase I dose escalation portion of this study.
Patients are followed for disease progression.
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
-
-
New York
-
Bronx、New York、アメリカ、10461
- Albert Einstein Comprehensive Cancer Center
-
New York、New York、アメリカ、10016
- NYU School of Medicine's Kaplan Comprehensive 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
DISEASE CHARACTERISTICS:
- Histologically or clinically confirmed metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin normal
- Proven Gilbert's syndrome (UGT1A1 promoter mutation or clinical
- documentation of stress bilirubin levels) allowed
- AST/ALT no greater than 3 times upper limit of normal
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Pulmonary:
- No unexplained respiratory problems (e.g., nonproductive cough, dyspnea,
- rales, pulmonary infiltrates, hypoxia, or tachypnea)
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No clinical evidence of neuropathy
- No prior allergy to platinum compounds
- No prior allergy to antiemetics appropriate for administration in
- conjunction with protocol directed chemotherapy
- No other concurrent uncontrolled illness (e.g., active infection)
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and
- platinum) and recovered
- No more than 1 prior chemotherapy regimen for cancer
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Other:
- No concurrent antiretroviral agents (HAART)
- No other concurrent investigational agents or commercial therapies
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：アームⅠ
詳細な説明を参照してください。
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Basu S, Goel S, Hochster H, et al.: Phase I and pharmacokinetic (PK) study of oxaliplatin (Ox) with gemcitabine (Gem) and continuous intravenous (CIV) infusion 5-fluorouracil (FU) in patients with advanced solid malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2132, 2002.
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。
フルオロウラシルの臨床試験
-
Encube Ethicals Pvt. Ltd.CBCC Global Research完了
-
Massachusetts General HospitalStand Up To Cancer募集