Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.
Secondary
- Determine the objective response and stabilization rate in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine overall survival rate in patients treated with this regimen.
- Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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-
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Dijon、フランス、21000
- Hopital Drevon
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Lille、フランス、59037
- Centre Hospital Universitaire Hop Huriez
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Lyon、フランス、69008
- Clinique Saint Jean
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Marseille、フランス、13008
- Hopital Saint Joseph
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Montfermeil、フランス、93370
- Intercommunal Hospital
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Neuilly Sur Seine、フランス、F-92202
- American Hospital of Paris
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Paris、フランス、75015
- Hôpital Europeén Georges Pompidou
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Paris、フランス、75018
- Hopital Bichat - Claude Bernard
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Paris、フランス、75970
- Hôpital Tenon
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Paris、フランス、75571
- Hopital Saint Antoine
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Pontoise、フランス、95300
- Clinique Ste - Marie
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Reims、フランス、F-51100
- Polyclinique de Courlancy
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Saint Brieuc、フランス、F-22015
- Clinique Armoricaine de Radiologie
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Strasbourg、フランス、67010
- Clinique de l'Orangerie
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Suresnes、フランス、92151
- Centre Medico-Chirurgical Foch
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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 confirmed colorectal adenocarcinoma
- Metastatic, unresectable disease
Meets 1 of the following criteria:
- At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan
- Evaluable disease
- Evidence of disease (e.g., ascites or bone metastases) by imaging techniques
Progressive disease as defined by 1 of the following criteria:
- Progressive disease while receiving first-line chemotherapy
- Recurrent disease within 6 months after completing adjuvant chemotherapy
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 80
Performance status
- WHO 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 3 times ULN
Renal
- Not specified
Cardiovascular
- No uncontrolled angina
- No myocardial infarction within the past 6 months
Gastrointestinal
- No chronic diarrhea grade 2 or greater
- No unresolved fully or partially obstructed intestine
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other underlying disease or medical condition that would preclude study participation
- No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix
- No psychological, social, familial, or geographical condition that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior irinotecan
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy
Surgery
- At least 3 weeks since prior surgery
Other
- No other concurrent clinical trial participation
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
- マスキング：なし（オープンラベル）
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 |
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進行までの時間
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Time to death from progression
|
二次結果の測定
結果測定 |
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客観的な反応
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治療失敗までの時間
|
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応答時間
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全生存率
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Stabilization rate
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Incidence of grade 3 or 4 toxicity
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協力者と研究者
捜査官
- May Mabro, MD、Hôpital Foch
研究記録日
主要日程の研究
研究開始
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
- CDR0000347378
- FRE-GERCOR-FOLFIRI3-C00-2
- EU-20333
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