- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01413750
Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Small Cell Lung Cancer
Phase II Randomized Study of Vorinostat or Placebo in Combination With Carboplatin and Paclitaxel for Patients With Advanced Non-small Cell Lung Cancer
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To compare progression-free survival associated with the combination of carboplatin, paclitaxel and vorinostat versus carboplatin, paclitaxel and placebo for patients with previously untreated, advanced NSCLC.
SECONDARY OBJECTIVES:
I. To determine the response rate, time to treatment failure, and overall survival for the two regimens.
II. To assess the safety profile of the regimen of vorinostat, carboplatin and paclitaxel for patients with advanced NSCLC.
III. To understand the mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood and archived tumor tissue.
An initial safety run-in study is planned (phase I) before starting the phase II randomized study as described below. Doses of Vorinostat to be tested during the safety run-in portion are: Dose Level -1 500 mg QD, Dose Level 1 600 mg QD, Dose Level 2 800 mg QD. Patients will not be randomized during the safety lead-in period, and no patients treated during the lead-in will be considered in the primary evaluation of each arm in any comparison. Once the safety run-in portion is completed, all patients will randomized to receive either placebo or vorinostat at a fixed dose determined during the run-in portion.
Phase II Portion of Study:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on day 0. Patients also receive vorinostat orally (PO) once daily on days -2 to 2.
ARM II: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive placebo PO once daily on days -2 to 2.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, quarterly for 1 year, and then twice a year thereafter.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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Duarte, California, 미국, 91010
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, 미국, 90033
- USC / Norris Comprehensive Cancer Center
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Sacramento, California, 미국, 95817
- University of California Davis Comprehensive Cancer Center
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Florida
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Tampa, Florida, 미국, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University/Winship Cancer Institute
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Illinois
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Peoria, Illinois, 미국, 61615
- Illinois CancerCare-Peoria
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Springfield, Illinois, 미국, 62794
- Southern Illinois University School of Medicine - Obstetrics and Oncology
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Missouri
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Saint Louis, Missouri, 미국, 63141
- Saint John's Mercy Medical Center
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033-0850
- Penn State Milton S Hershey Medical Center
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Pittsburgh, Pennsylvania, 미국, 15232
- University of Pittsburgh
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Pittsburgh, Pennsylvania, 미국, 15232
- University of Pittsburgh Cancer Institute
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt-Ingram Cancer Center
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Virginia
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Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University/Massey Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must have histologically confirmed non-small cell lung cancer
- No prior chemotherapy for advanced or metastatic disease
- ECOG performance status 0 or 1
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
- Life expectancy of greater than 12 weeks
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy in a metastatic setting
- Patients may not be receiving any other investigational agents
- Patients with untreated brain metastases should be excluded from this clinical trial; however, patients who have stable brain disease (should be off corticosteroids) at least 3 weeks after completion of appropriate therapy are eligible
- Patients who have received any prior HDAC inhibitor (except valproic acid for seizure control provided that the valproic acid has been stopped at least 30 days before beginning therapy on this protocol) are excluded from this study
- Peripheral neuropathy of severity greater than grade 1
- Known history of allergic reactions to paclitaxel
- Prior therapy with paclitaxel
- Inability to take oral medications on a continuous basis; patients unable to swallow the vorinostat capsules whole are ineligible (the capsules cannot be crushed or broken)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with vorinostat; women of childbearing potential must use an appropriate double barrier method of birth control (such as female use of a diaphragm, intrauterine device [IUD], sponge and spermicide, in addition to the male use of a condom) or a prescribed birth control implant or practice abstinence; both double barrier contraception and implants must be used for at least one week prior to the start of the research study and continue for at least two weeks following the last study visit; please note that birth control pills should not be used while on this study as they may have a negative interaction with the experimental drug in this study
- HIV-positive patients receiving combination antiretroviral therapy are ineligible
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Arm I (paclitaxel, carboplatin, vorinostat)
Patients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on day 0. Patients also receive vorinostat PO once daily on days -2 to 2.
|
상관 연구
주어진 IV
주어진 IV
다른 이름들:
주어진 PO
다른 이름들:
|
활성 비교기: Arm II (paclitaxel, carboplatin, placebo)
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive placebo PO once daily on days -2 to 2.
|
상관 연구
주어진 IV
주어진 PO
다른 이름들:
주어진 IV
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression-free Survival (PFS)
기간: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year
|
Estimated using the product-limit method of Kaplan and Meier. PFS defined as time from randomization to progression or death due to any cause. Progression defined as Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Dose Limiting Toxicity (DLT) (Phase I)
기간: 4 weeks from start of treatment, up to 1 year
|
DLT is defined as any grade III or higher non-hematological toxicity except nausea, vomiting or alopecia.
Nausea or vomiting (> grade 2) that last longer than 48 hours despite maximal medical therapy.
Absolute neutrophil count < 1000/uL lasting longer than 7 days.
Grade 4 thrombocytopenia (platelet < 25,000/uL).
Grade 3 or 4 neutropenia associated with sepsis or fever > 38 C. Delay in starting cycle 2 by more than 2 weeks due to toxicity.Abnormal non-hematological laboratory criteria (Grade 3 or higher) will be considered a DLT, if clinically significant and drug-related.
If baseline value is elevated prior to drug therapy, an increase will not be considered a DLT unless there is an elevation by more than 2 grades, and it is of clinical significance.
Dose escalation schedule for vorinostat: 600 mg QD; 800 mg QD.
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4 weeks from start of treatment, up to 1 year
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Maximum Tolerated Dose (MTD) (Phase I)
기간: 4 weeks from start of treatment, up to 1 year
|
The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity.
The MTD is one dose level below the lowest dose in which 33% or more of the patients experience a DLT.
The MTD is based on the first cycle of therapy.
The recommended Phase II dose is generally the MTD, although secondary considerations of toxicity and dose reductions on subsequent cycles and other secondary considerations may result in the recommended Phase II dose being below the MTD.
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4 weeks from start of treatment, up to 1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Chandra Belani, MD, University of Pittsburgh
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
- NCI-2010-02203 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- P30CA033572 (미국 NIH 보조금/계약)
- U01CA099168 (미국 NIH 보조금/계약)
- N01CM62209 (미국 NIH 보조금/계약)
- N01CM00071 (미국 NIH 보조금/계약)
- N01CM00038 (미국 NIH 보조금/계약)
- N01CM00100 (미국 NIH 보조금/계약)
- 8703 (CTEP)
- PHII-102 (기타 식별자: City of Hope Comprehensive Cancer Center)
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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