- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00459342
Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Phase II Study of Dasatinib in Non Small Cell Lung Cancer
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib.
SECONDARY OBJECTIVES:
I. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and (phosphorylated Src) pSrc expression levels in pre-treatment tumor biopsies.
III. Determine the toxicity of this drug.
OUTLINE:
Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor and by immunohistochemistry for pSrc expression.
연구 유형
등록 (실제)
단계
- 2 단계
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:
- Platelet count >= 100,000/mm^3
Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following criteria:
- Stage IV disease
- Stage IIIB disease with pleural effusion
- Recurrent disease after surgery or radiotherapy
- Measurable disease, defined as >= 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- Previously treated brain metastasis allowed, provided there is no bleeding, no midline shift, no need for steroids or anti-convulsants, and no symptoms
- Must agree to obtain residual tumor tissue available from the existing diagnostic biopsy tumor tissue
- Eastern cooperative oncology group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- White blood cell (WBC) >= 3,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and ALT =< 2.5 times ULN
- Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min
- No uncontrolled congestive heart failure or potentially life-threatening arrhythmia
- No angina at rest
- No neuropathy >= grade 2
- No chronic diarrhea or history of inflammatory bowel disease
- No history of pulmonary fibrosis (other than in an irradiated field)
- No other concurrent serious medical illness
- O2 saturation > 92% on room air
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions to compounds of similar chemical or biological composition to dasatinib
- No heart rate-corrected QT interval (QTc) prolongation (i.e., QTC >= 480 msec) or other significant ECG abnormalities that could lead to adverse effects if the QTc interval were prolonged
No medical condition that impairs the ability to swallow, retain, or absorb dasatinib including, but not limited to, any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
- No myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- left ventricular ejection fraction (LVEF) normal
- No major conduction abnormality (unless cardiac pacemaker is present)
- No ongoing or active infection
- No history of significant bleeding disorder (congenital [von Willebrand's disease] or acquired [antifactor VIII antibodies])
- No psychiatric illness or social situation that would preclude study compliance
- No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell lung cancer
- Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with radiation for locally advanced disease (curative intent) allowed provided disease recurrence >= 3 months after completion of last chemotherapy dose
- Measurable disease must be outside the radiotherapy port OR clearly growing inside the port
- No prior radiotherapy to >= 25% of the marrow-containing skeleton
- At least 7 days since prior and no concurrent medications that are inhibitors or inducers of CYP3A4
- At least 7 days since prior and no concurrent agents with proarrhythmic potential
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)
- Locally acting antacids allowed except for 2 hours before and after dasatinib administration
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: Arm I
Patients received oral dasatinib twice daily on days 1-21.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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구두로 주어진
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
기간: 12 weeks
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Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
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12 weeks
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Progression-free Survival (PFS)
기간: Time from start of treatment to time of progression or death, assessed at 2 months
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Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.
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Time from start of treatment to time of progression or death, assessed at 2 months
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기타 결과 측정
결과 측정 |
기간 |
---|---|
Time to Progression (TTP)
기간: Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks
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Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks
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Epidermal Growth Factor Receptor (EGFR) Mutational Status
기간: Baseline
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Baseline
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Epidermal Growth Factor Receptor (EGFR) Copy Number
기간: Baseline
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Baseline
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Phospho-Src (pSrc) Expression
기간: Baseline
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Baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Faye Johnson, M.D. Anderson Cancer Center
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCI-2009-00225 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- P30CA016672 (미국 NIH 보조금/계약)
- N01CM62202 (미국 NIH 보조금/계약)
- 7798 (기타 식별자: CTEP)
- CDR0000538668
- 2006-0593 (기타 식별자: M D Anderson 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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