Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
Phase II Study in Patients With Metastatic Colorectal Carcinoma Previously Treated With Oxaliplatin (OXAL) or a Combination of Irinotecan (CPT-11) and OXAL
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan.
연구 개요
상세 설명
OBJECTIVES:
- Determine the tumor response rate in patients receiving irinotecan or fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin with or without irinotecan.
- Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Evaluate the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy). Patients are assigned to one of two treatment groups.
- Group I (prior oxaliplatin-based chemotherapy): Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks.
- Group II (prior irinotecan and oxaliplatin combination chemotherapy): Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks.
- Both groups: Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion.
Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment.
Patients are followed every 3 months for 5 years.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, 미국, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, 미국, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, 미국, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, 미국, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, 미국, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, 미국, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, 미국, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, 미국, 68106
- CCOP - Missouri Valley Cancer Consortium
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South Dakota
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Rapid City, South Dakota, 미국, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, 미국, 57104
- CCOP - Sioux Community Cancer Consortium
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Saskatchewan
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Regina, Saskatchewan, 캐나다, S4T 7T1
- Allan Blair Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not amenable to radiotherapy with curative intent
Progressive disease after one of the following prior treatments for metastatic disease:
- Oxaliplatin-based chemotherapy
- Irinotecan and oxaliplatin combination chemotherapy
At least 1 measurable lesion
- At least 20 mm in at least one dimension
- No known CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)
- AST no greater than 5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina
- No symptomatic congestive heart failure
- No serious uncontrolled cardiac arrhythmia
Other:
- No active or uncontrolled infection
- No evidence of other serious illness
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent sargramostim (GM-CSF)
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No more than 1 prior chemotherapy regimen for advanced colorectal cancer
- Prior adjuvant chemotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to more than 25% of bone marrow
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: irinotecan
Prior oxaliplatin-based chemotherapy: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years. |
|
|
실험적: leucovorin + fluorouracil
Prior to irinotecan and oxaliplatin combination chemotherapy: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
종양 반응률
기간: 최대 5년
|
최대 5년
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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전반적인 생존
기간: 최대 5년
|
최대 5년
|
|
삶의 질
기간: 최대 5년
|
최대 5년
|
|
time to tumor progression
기간: Up to 5 years
|
Up to 5 years
|
|
치료 실패까지의 시간
기간: 최대 5년
|
최대 5년
|
공동 작업자 및 조사자
수사관
- 연구 의자: Henry C. Pitot, MD, Mayo Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
- NCCTG-N0048
- NCI-2012-02383 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
- CDR0000068635 (레지스트리 식별자: PDQ (Physician Data Query))
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