Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
A Phase 1 Study of PS-341 in Combination With Docetaxel in Patients With Advanced Solid Tumors
연구 개요
상세 설명
OBJECTIVES:
I. Determine the maximum tolerated dose of bortezomib and docetaxel in patients with advanced solid tumors.
II. Determine the toxicity and tolerability of this regimen in these patients. III. Determine the biologic correlates of proteasome inhibition of bortezomib and determine the effects of this inhibition on the pharmacokinetics of docetaxel in these patients.
IV. Determine the antitumor efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
For course 1, patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12. Patients then receive 1 week of rest. For course 2 and all subsequent courses, patients receive docetaxel on days 1 and 8 and bortezomib on days 2, 5, 9, and 12. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21287-8936
- Johns Hopkins University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Histologically confirmed solid tumor for which standard curative or palliative measures do not exist or are no longer effective
- Metastatic or unresectable disease
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100%
- More than 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
- Bilirubin normal
- AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 5 times ULN (unless bone-derived) and AST and ALT less than 1.5 times ULN
- Creatinine normal
- 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 during and for 3 months after study
- No prior allergic reactions attributed to taxanes (e.g., docetaxel or paclitaxel) or compounds of similar chemical or biological composition
- No prior allergic reactions to compounds similar to bortezomib or other study agents
- No known hypersensitivity to corticosteroids
- No predicted intolerance to regular, repeated administration of corticosteroids (e.g., poorly controlled diabetes or significant osteoporosis/osteopenia)
- No ongoing or active infection
- No other uncontrolled concurrent illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study participation
- No peripheral neuropathy grade 2 or greater
At least 4 weeks since prior chemotherapy (6 weeks for carmustine, nitrosoureas, or mitomycin) and recovered
- No more than 3 courses of mitomycin
Prior taxanes allowed
- At least 6 months since prior docetaxel administered on a weekly schedule
- At least 4 weeks since prior radiotherapy and recovered
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies (commercial or investigational)
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 (docetaxel, bevacizumab)
For course 1, patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12. Patients then receive 1 week of rest.
For course 2 and all subsequent courses, patients receive docetaxel on days 1 and 8 and bortezomib on days 2, 5, 9, and 12. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
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상관 연구
주어진 IV
다른 이름들:
상관 연구
다른 이름들:
주어진 IV
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0
기간: 21 days
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21 days
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Toxicity and tolerability as assessed by NCI CTC version 2.0
기간: Up to 30 days after completion of study treatment
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Up to 30 days after completion of study treatment
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Pharmacokinetics of docetaxel
기간: At baseline, at 30 and 60 during infusion, at 10 min, 30 min, 1, 3, 7.5, 24, and 48 hours, and at 8 days after completion of docetaxel infusion
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At baseline, at 30 and 60 during infusion, at 10 min, 30 min, 1, 3, 7.5, 24, and 48 hours, and at 8 days after completion of docetaxel infusion
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Response rate
기간: Up to 30 days after completion of study treatment
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Up to 30 days after completion of study treatment
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20S proteasome activity
기간: At 1 hour after first PS-341 infusion (week 2, day 2), and at 24 and 48 hours
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At 1 hour after first PS-341 infusion (week 2, day 2), and at 24 and 48 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Deborah Armstrong, Johns Hopkins University
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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