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.
연구 개요
상세 설명
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.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Dijon, 프랑스, 21000
- Hopital Drevon
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Lille, 프랑스, 59037
- Centre Hospital Universitaire Hop Huriez
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Lyon, 프랑스, 69008
- Clinique Saint Jean
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Marseille, 프랑스, 13008
- Hopital Saint Joseph
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Montfermeil, 프랑스, 93370
- Intercommunal Hospital
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Neuilly Sur Seine, 프랑스, F-92202
- American Hospital of Paris
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Paris, 프랑스, 75015
- Hôpital Europeén Georges Pompidou
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Paris, 프랑스, 75018
- Hopital Bichat - Claude Bernard
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Paris, 프랑스, 75970
- Hôpital Tenon
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Paris, 프랑스, 75571
- Hopital Saint Antoine
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Pontoise, 프랑스, 95300
- Clinique Ste - Marie
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Reims, 프랑스, F-51100
- Polyclinique de Courlancy
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Saint Brieuc, 프랑스, F-22015
- Clinique Armoricaine de Radiologie
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Strasbourg, 프랑스, 67010
- Clinique de l'Orangerie
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Suresnes, 프랑스, 92151
- Centre Medico-Chirurgical Foch
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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진행 시간
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Time to death from progression
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2차 결과 측정
결과 측정 |
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객관적 대응
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치료 실패까지의 시간
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응답 기간
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전반적인 생존율
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Stabilization rate
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Incidence of grade 3 or 4 toxicity
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공동 작업자 및 조사자
수사관
- May Mabro, MD, Hôpital Foch
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000347378
- FRE-GERCOR-FOLFIRI3-C00-2
- EU-20333
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