S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction.
연구 개요
상세 설명
OBJECTIVES:
- Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction.
- Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients.
- Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010-3000
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, 미국, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Sacramento, California, 미국, 95817
- University of California Davis Cancer Center
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Illinois
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Maywood, Illinois, 미국, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Kansas
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Kansas City, Kansas, 미국, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, 미국, 44106
- Case Comprehensive Cancer Center
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Independence, Ohio, 미국, 44131
- Community Oncology Group at Cleveland Clinic Cancer Center
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Wooster, Ohio, 미국, 44691
- Cleveland Clinic - Wooster
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Texas
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Fort Sam Houston, Texas, 미국, 78234
- Brooke Army Medical Center
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Lackland AFB, Texas, 미국, 78236
- Wilford Hall Medical Center
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San Antonio, Texas, 미국, 78229-3900
- University of Texas Health Science Center at San Antonio
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Washington
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Bellingham, Washington, 미국, 98225
- St. Joseph Hospital Community Cancer Center
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Bremerton, Washington, 미국, 98310
- Olympic Hematology and Oncology
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Mt. Vernon, Washington, 미국, 98273
- Skagit Valley Hospital Cancer Care Center
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Seattle, Washington, 미국, 98104
- Harborview Medical Center
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Seattle, Washington, 미국, 98104
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, 미국, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle, Washington, 미국, 98195-6043
- University Cancer Center at University of Washington Medical Center
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Seattle, Washington, 미국, 98104-1387
- Group Health Central Hospital
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Sedro-Wooley, Washington, 미국, 98284
- North Puget Oncology at United General Hospital
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Spokane, Washington, 미국, 99202
- Cancer Care Northwest - Spokane South
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Wenatchee, Washington, 미국, 98801-2028
- Wenatchee Valley Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective
- Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma
- Any solid tumor or lymphoma tumor type eligible
- Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry
Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month
- Prior whole brain or gamma knife radiotherapy required for known brain metastases
- No unstable or untreated (non-irradiated) brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No active hemolysis
Hepatic
- See Disease Characteristics
- Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable
- Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes)
- No evidence of biliary sepsis
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- No concurrent uncontrolled illness
- No ongoing or active infection
- No uncontrolled diarrhea
- No peripheral neuropathy grade II or greater
- No psychiatric illness or social situation that would preclude study compliance
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy for malignancy
Chemotherapy
- More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy for malignancy
Endocrine therapy
- See Disease Characteristics
- No concurrent oral contraceptives
No concurrent hormone therapy for malignancy
- Concurrent luteinizing hormone-releasing hormone agonists allowed
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy for malignancy
Surgery
- More than 2 weeks since prior major surgery
Other
- Recovered from prior therapy
- No concurrent medications that are known to be inhibitors of CYP3A4
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 |
|---|---|
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실험적: treatment
Single-arm, dose-escalation of BMS-247550
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BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
dose defining
기간: Treatment delays >2 weeks constitute a DLT
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Treatment delays >2 weeks constitute a DLT
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression
기간: 30 days after going off study
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20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline.
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30 days after going off study
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Symptomatic deterioration
기간: 30 days after going off study
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Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
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30 days after going off study
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chris H. Takimoto, MD, PhD, Institute for Drug Development
간행물 및 유용한 링크
일반 간행물
- Takimoto CH, Liu PY, Lenz H, et al.: A phase I pharmacokinetic (PK) study of the epothilone B analogue, ixabepilone (BMS-247550) in patients (pts) with advanced malignancies and varying degrees of hepatic impairment. A SWOG Early Therapeutics Committee and NCI Organ Dysfunction Working Group Trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-2004, 2006.
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
키워드
- 상세불명의 성인 고형 종양, 프로토콜 특이적
- IV기 성인 면역모세포성 대세포 림프종
- 재발성 성인 미만성 대세포 림프종
- 재발성 성인 면역모세포성 대세포 림프종
- 재발성 성인 버킷 림프종
- 재발성 성인 호지킨 림프종
- 재발성 성인 미만성 소절단 세포 림프종
- 재발성 성인 미만성 혼합 세포 림프종
- 4기 성인 미만성 소절단 세포 림프종
- IV기 맨틀 세포 림프종
- 재발성 변연부 림프종
- 재발성 소림프구성 림프종
- 4기 소림프구성 림프종
- IV기 변연부 림프종
- 결절 변연부 B 세포 림프종
- 비장 변연부 림프종
- 재발성 성인 림프구성 림프종
- 재발성 맨틀 세포 림프종
- IV기 피부 T 세포 비호지킨 림프종
- 재발 성 피부 T 세포 비호 지킨 림프종
- 소장 림프종
- IV기 성인 림프구성 림프종
- 4기 성인 T세포 백혈병/림프종
- 재발성 성인 T 세포 백혈병/림프종
- 안내 림프종
- 혈관면역모세포성 T세포 림프종
- 역형성 대세포 림프종
- 원발성 중추신경계 림프종
- recurrent grade 1, 2, or 3 follicular lymphoma
- stage IV adult diffuse large cell or mixed cell lymphoma
- stage IV adult Burkitt lymphoma or Hodgkin lymphoma
- stage IV grade 1, 2, or 3 follicular lymphoma
- extranodal marginal zone B-cell lymphoma of MALT
추가 관련 MeSH 약관
기타 연구 ID 번호
- S0355 (기타 식별자: SWOG)
- U10CA032102 (미국 NIH 보조금/계약)
- P30CA016087 (미국 NIH 보조금/계약)
- U01CA076642 (미국 NIH 보조금/계약)
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