- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00083148
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capecitabine kill more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer.
연구 개요
상세 설명
OBJECTIVES:
- Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer.
- Determine the degree of accumulation of cells in S-phase in tumor biopsies from patients treated with this regimen.
- Determine the dose-limiting toxicity and other major or unusual toxic effects of this regimen in these patients.
- Determine any antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen, including the active metabolite SN-38, in these patients.
- Correlate pharmacokinetic parameters of this regimen with the biological changes observed in these patients.
- Determine, preliminarily, the relationship of tumor response with modulation of S-phase in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 1.5 hours on days 1, 8, 22, and 29 and oral capecitabine twice daily on days 1-14 and 23-36. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 8-37 patients will be accrued for this study within 18-24 months.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
New York
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Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer not eligible for potentially curative therapy or studies of higher priority
- Advanced disease
- Tumor accessible to biopsy AND not irradiated
- Failed at least 1 prior chemotherapy regimen (not including adjuvant chemotherapy)
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- AST ≤ 2 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 50 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active uncontrolled bacterial, viral, or fungal infection
- No poor medical risk from non-malignant systemic disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- Prior irinotecan allowed
- Prior carboplatin allowed
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy except for small port radiotherapy for local control
Surgery
- More than 4 weeks since prior major surgery
Other
- No concurrent high-dose IV cyclosporine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
공동 작업자 및 조사자
수사관
- 수석 연구원: Tracey O'Connor, MD, Roswell Park Cancer Institute
간행물 및 유용한 링크
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
- CDR0000363790
- RPCI-RP-0221
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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