- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00080990
Alvocidib, Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Treating Patients With Advanced Solid Tumors
An Open-Labeled, Non-Randomized Phase I Study of Alvocidib (Flavopiridol) Administered With Oxaliplatin and Fluorouracil/Leucovorin in Patients With Advanced Solid Tumors
연구 개요
상세 설명
OBJECTIVES:
I. Determine the maximum tolerated dose of flavopiridol when given in combination with oxaliplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors.
II. Determine the pharmacokinetics of this regimen in these patients. III. Determine, preliminarily, the therapeutic activity of this regimen in these patients.
IV. Determine the dose-limiting toxicity and the recommended phase II dose of flavopiridol when administered with this regimen in these patients.
V. Determine the safety and tolerability of this regimen in these patients. VI. Correlate p21, p53, and apoptotic markers with response in patients treated with this regimen.
OUTLINE: This is a non-randomized, open-label, dose-escalation study of flavopiridol.
Patients receive alvocidib intravenously (IV) over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of alvocidib 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. Once the MTD is determined, the cohort is expanded and an additional 10 patients are treated at that dose.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10065
- Memorial Sloan-Kettering Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Histologically confirmed advanced solid tumor
- Refractory to standard therapy or no standard therapy exists
- Evaluable disease
No known untreated CNS metastases
- Patients who have undergone local treatment for brain metastases and whose brain metastases are stable by repeat imaging study performed ≤ 4 weeks after treatment are allowed
- No primary CNS tumors
- Performance status - Karnofsky 60-100%
- WBC ≥ 3,500/mm^3
- Neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for liver metastases)
- Creatinine ≤ 1.5 mg/dL
- No cardiac arrhythmias within the past 6 months
- No congestive heart failure within the past 6 months
- No myocardial infarction within the past 6 months
- No arterial or venous thrombosis within the past year
- No peripheral neuropathy > grade 1
- No other medical condition that would preclude study participation
- No serious or uncontrolled infection
- HIV negative
Not pregnant or nursing
- No nursing during and for 2 months after study participation
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- At least 2 weeks since prior immunotherapy
- At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
- No prior flavopiridol
- At least 2 weeks since prior radiotherapy
- Recovered from all prior therapy
No concurrent therapy for thrombosis
- Prophylaxis for central lines or deep vein thrombosis allowed
- No other concurrent investigational medications
No concurrent vitamins, antioxidants, or herbal preparations and supplements
- Concurrent single-tablet multivitamin allowed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Treatment (alvocidib with oxaliplatin, 5-FU, leucovorin)
Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol 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. Once the MTD is determined, the cohort is expanded and an additional 10 patients are treated at that dose. |
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Maximum tolerated dose of biweekly alvocidib when given in conjunction with oxaliplatin, 5-fluorouracil, and leucovorin calcium
기간: 6 weeks
|
Defined as the dose level immediately preceding the dose where 2 or more patients experienced dose-limiting toxicity.
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6 weeks
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Dose-limiting toxicity as defined by the occurrence of Grade 4 hematologic toxicity, Grade 3 or 4 non-hematologic toxicity including diarrhea despite antidiarrheal prophylaxis, or any delay in treatment resulting in less than 3 treatments in 6 weeks
기간: 6 weeks
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6 weeks
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Recommended phase II dose of alvocidib
기간: 6 weeks
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6 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gary Schwartz, Memorial Sloan Kettering Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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
- NCI-2009-00055 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- U01CA069856 (미국 NIH 보조금/계약)
- MSKCC-03146
- CDR0000357606
- NCI-6365
- 03-146A (기타 식별자: Memorial Sloan-Kettering Cancer Center)
- 6365 (기타 식별자: CTEP)
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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