- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00253344
Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors
Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors.
Secondary
- Determine the safety of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.
Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
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Ohio
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Cleveland, Ohio, 미국, 44106-5065
- Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
- Advanced disease
- Refractory to standard therapy OR no standard therapy exists
- Measurable or evaluable disease
No active brain metastases
- Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- At least 4 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
Renal
- Creatinine ≤ 2 mg/dL
Cardiovascular
- No New York Heart Association class III or IV heart disease
Immunologic
- No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide
- No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
- No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other uncontrolled illness or other condition that would preclude study compliance
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent hematopoietic growth factors during course 1 of study treatment
- No concurrent immunotherapy
Chemotherapy
At least 6 weeks since prior mitomycin or nitrosoureas
- No more than 2 prior courses of mitomycin
- No other concurrent chemotherapy
Radiotherapy
- No prior pelvic radiotherapy
Other
- At least 4 weeks since prior anticancer therapy
- No concurrent warfarin for anticoagulation (heparin is allowed)
- Recovered from all prior treatment
- No other concurrent anticancer therapy except bisphosphonates
- No other concurrent investigational agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Maximum tolerated dose
기간: measured at end of phase I
|
measured at end of phase I
|
|
Dose-limiting toxicity
기간: measured after every course
|
measured after every course
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Disease response
기간: measured after every 2 courses
|
measured after every 2 courses
|
공동 작업자 및 조사자
수사관
- 연구 의자: Matthew M. Cooney, MD, Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
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
- CASE2Y04 (기타 식별자: Case Comprehensive Cancer Center)
- P30CA043703 (미국 NIH 보조금/계약)
- AVENTIS-CASE-2Y04
- CELGENE-CASE-2Y04
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