- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00028561
BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
A Phase I Study of Epothilone B Analog BMS 247550 in Combination With Carboplatin in Recurrent and/or Refractory Solid Tumors
연구 개요
상세 설명
OBJECTIVES:
I. Determine the maximum tolerated dose of BMS-247550 when given in combination with carboplatin in patients with recurrent or refractory solid tumors.
II. Determine the dose-limiting toxicity and safety of this regimen in these patients.
III. Determine the plasma pharmacokinetics of this regimen in these patients. IV. Determine, preliminarily, any antitumor activity of this regimen in these patients.
V. Correlate the protein expression of survivin with the expression of other apoptotic regulators, the apoptotic index, and response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of BMS-247550.
Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15 followed by carboplatin IV over 1 hour on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR or up to a total of 6 courses. The first two cohorts of 3-6 patients each receive escalating doses of BMS-247550 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 (DLT).The third and fourth cohorts of 10 patients each receive escalating doses of BMS-247550 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 10 patients experience DLT. Once the MTD is determined for the third and fourth cohorts, 15 additional patients are treated at the MTD. Patients are followed for 30 days.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Tampa, Florida, 미국, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
- Measurable or evaluable disease
Lesion accessible for core or excisional biopsy if being treated at the maximum tolerated dose (MTD)
- No biliary tract dilation if radiologically guided biopsy of the liver is planned
- No requirement for core biopsy of lung lesion that is not pleural based
- No requirement for laparotomy or thoracotomy solely for biopsy
- No medical condition that would preclude biopsy
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - ECOG 0-1 if being treated at the MTD
- More than 3 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No prior bleeding disorder or unexplained bleeding if being treated at the MTD
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- PT/PTT normal
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent uncontrolled illness that would preclude study participation
- No ongoing or active infection
- No grade 2 or greater neuropathy (sensory or motor)
- No prior severe allergic reaction attributable to compounds containing Cremophor EL or platinum agents
- No psychiatric illness or social situation that would preclude study compliance
- No medical condition that would preclude study if being treated at the MTD
- At least 4 week since prior immunotherapy
- At least 24 hours since prior growth factors
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No more than 3 prior chemotherapy regimens
- No prior epothilone agents
- At least 1 week since prior hormonal therapy directed at malignancy
- Concurrent hormone replacement therapy allowed
- At least 4 weeks since prior wide-field radiotherapy involving 30% or more of bone marrow
- See Disease Characteristics
- At least 4 weeks since prior investigational agents
- No prior or concurrent St. John's Wort
- No concurrent combination anti-retroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No concurrent heparin or other anticoagulants if being treated at the MTD
- No concurrent inhibitors of cytochrome P450 3AP (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 |
---|---|
실험적: Treatment (ixabepilone, carboplatin)
Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15 followed by carboplatin IV over 1 hour on day 1.
Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients with a CR receive 2 additional courses after achieving CR or up to a total of 6 courses
|
상관 연구
상관 연구
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
MTD of ixabepilone defined as the first dosage tier below the MAD in which =< 1/6 patients experiences a DLT
기간: 28 days
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28 days
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Pharmacokinetics of ixabepilone and carboplatin
기간: Week 1
|
Week 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Daniel Sullivan, H. Lee Moffitt Cancer Center and Research Institute
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 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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