- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00028015
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
연구 개요
상세 설명
OBJECTIVES:
- Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer.
- Determine the qualitative and quantitative toxicity of this drug in these patients.
- Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Manitoba
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Winnipeg, Manitoba, 캐나다, R3E 0V9
- CancerCare Manitoba
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Ontario
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Kingston, Ontario, 캐나다, K7L 5P9
- Kingston Regional Cancer Centre
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Ottawa, Ontario, 캐나다, K1H 1C4
- Ottawa Regional Cancer Centre
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Toronto, Ontario, 캐나다, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, 캐나다, H2W 1S6
- McGill University
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Montreal, Quebec, 캐나다, H2L 4MI
- Hopital Notre- Dame du CHUM
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
- Locally recurrent or metastatic disease
- Previously treated with 1 chemotherapy regimen for recurrent or metastatic disease
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- No prior radiotherapy to indicator lesion (clear disease progression or new lesion within a prior radiation port is acceptable)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 120,000/mm^3
Hepatic:
- Bilirubin normal
- AST and ALT no greater than 2.5 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:
- DLCO at least 80% predicted
- FVC at least 80% predicted
- No history of significant pulmonary disease
- No concurrent symptomatic pulmonary disease (e.g., chronic obstructive pulmonary disorder, chronic asthma)
Other:
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- No other serious illness or medical condition that would preclude study
- No ongoing or active uncontrolled infection
- No history of significant neurologic or psychiatric disorder that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- Prior adjuvant chemotherapy allowed
- No prior nitrosoureas
- No prior second-line chemotherapy for recurrent or metastatic disease
- At least 4 weeks since prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- See Disease Characteristics
- Prior radiotherapy as part of primary therapy allowed
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Prior surgery as part of primary therapy allowed
- Prior reoperation for recurrent disease allowed
- At least 2 weeks since prior surgery other than biopsy
Other:
- At least 4 weeks since prior investigational agent
- No other concurrent investigational agents or therapy
- No other concurrent anticancer therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
수사관
- 연구 의자: Ralph PW Wong, MD, FRCPC, CancerCare Manitoba
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- I146
- CAN-NCIC-IND146 (기타 식별자: PDQ)
- CDR0000069113 (기타 식별자: PDQ)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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