- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00243100
Vorinostat and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
A Phase 1 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Gemcitabine in Patients With Epithelial Tumors
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. Determine the dose-limiting toxicity, maximum tolerated dose, and pharmacokinetics of vorinostat (SAHA) and gemcitabine in patients with metastatic or unresectable epithelial solid tumors.
SECONDARY OBJECTIVES:
II. Determine tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation, open-label study.
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and gemcitabine IV over 1-2 hours on days 3 and 10. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA and gemcitabine 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. A minimum of 6 patients are treated at the MTD.
After completion of study treatment, patients are followed for 30 days.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ECOG 0-2 OR Karnofsky 60-100%
- AST and ALT =< 2.5 times ULN
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- Platelet count >= 100,000/mm3
- Absolute neutrophil count >= 1,500/mm3
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Any number and type of prior chemotherapies are allowed including prior use of gemcitabine chemotherapy. A washout phase of at least 2 weeks since use of prior chemotherapy or radiation therapy, 6 weeks if the last regimen included nitrosoureas or mitomycin C, is required.
- Patients must have histologically confirmed epithelial malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must have at least one measurable lesion as per the RECIST Criteria that can be accurately measured in at least one dimension, with minimum lesion size equal to or more than twice the slice thickness of the imaging study used.
Exclusion Criteria:
- No symptomatic congestive heart failure
- No cardiac arrhythmia
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No history of allergy, significant side effects, or poor tolerance to gemcitabine
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat (SAHA)
- At least 2 weeks since prior radiotherapy
- Recovered from prior therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other uncontrolled illness
- More than 2 weeks since prior valproic acid
- No other concurrent investigational drugs
- No other concurrent anticancer therapy
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
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: Arm I
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and gemcitabine IV over 1-2 hours on days 3 and 10. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA and gemcitabine 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. A minimum of 6 patients are treated at the MTD |
주어진 IV
다른 이름들:
구두로 주어진
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Maximally tolerated dose of a combination of SAHA and gemcitabine determined by dose-limiting toxicity as measured by NCI CTCAE v3.0 continuously
기간: 21 days
|
21 days
|
Pharmacokinetics of SAHA
기간: -0.5, 0.5, 1, 2, 2.5, 3, 4, 6 and 8 hours after day 1 dose; -0.5 hours day 2; and -0.5, 0.5, 1, 2, 2.5, 3, 4, 6 and 8 hours day 3
|
-0.5, 0.5, 1, 2, 2.5, 3, 4, 6 and 8 hours after day 1 dose; -0.5 hours day 2; and -0.5, 0.5, 1, 2, 2.5, 3, 4, 6 and 8 hours day 3
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Best overall response (complete + partial response rate) as measured radiologically by RECIST
기간: Up to 6 years
|
Up to 6 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gauri Varadhachary, M.D. Anderson 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-2009-00091 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- U01CA062461 (미국 NIH 보조금/계약)
- CDR0000445401
- 2005-0140 (기타 식별자: M D Anderson Cancer Center)
- 6865 (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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