- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02775006
Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma
A Randomized Phase III Study of Docetaxel Versus Intercalated Erlotinib Docetaxel Combination Therapy in Patients With Relapsed EGFR (Epidermal Growth Factor Receptor) Wild Type, ALK(Anaplastic Lymphoma Kinase) Negative Non Squamous Cell Carcinoma. (NVALT 18 Study)
연구 개요
상세 설명
The aim of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.
As pemetrexed is standard first line treatment, the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment. Also the question has to be answered whether the combination outperforms monotherapy treatments.
After stratification for ECOG-performance status (0-1), response to prior treatment (CR, PR, SD versus PD), treatment free interval after platinum based therapy (<6 months versus >6 months) and maintenance, patients will be centrally randomized to receive either docetaxel (arm A) or docetaxel plus erlotinib (arm B).
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Apeldoorn, 네덜란드
- Gelre Ziekenhuis
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Breda, 네덜란드
- Amphia Hospital
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Den Bosch, 네덜란드
- Jeroen Bosch Hospital
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Den Haag, 네덜란드, 2545 CH
- Haga
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Dordrecht, 네덜란드
- Albert Schweitzer Ziekenhuis
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Ede, 네덜란드
- Ziekenhuis Gelderse Vallei
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Eindhoven, 네덜란드, 5631 BM
- Maxima Medisch Centrum
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Groningen, 네덜란드
- Martini Ziekenhuis
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Hoofddorp, 네덜란드, 2130 AT
- Spaarne Gasthuis
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Leeuwarden, 네덜란드, 8934 AD
- MCL
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Maastricht, 네덜란드
- Maastricht University Medical Center
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Roermond, 네덜란드
- Laurentius Hospital
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Rotterdam, 네덜란드
- Erasmus MC
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Rotterdam, 네덜란드, 3045 PM
- St. Fransicus Gasthuis
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Rotterdam, 네덜란드, 3083 AN
- Ikazia
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Utrecht, 네덜란드
- St. Antonius Ziekenhuis
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Venlo, 네덜란드
- VieCuri Medisch Centrum voor Noord-Limburg
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the Hague, 네덜란드
- Medical Center Haaglanden
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Noord-Holland
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Amsterdam, Noord-Holland, 네덜란드, 1081HV
- VUmc Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically confirmed EGFR wild type, ALK negative, non-squamous cell carcinoma, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one cytotoxic treatment platinum containing regimen. Immunotherapy pretreatment is allowed
- Complete recovery from prior chemotherapy side effects to < Grade 2.
- At least one unidimensionally measurable lesion meeting RECIST criteria.
- ECOG PS 0-1.
- Age ≥ 18 years.
Adequate organ function, including:
- Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets ≥ 100 x 109/L.
- Hepatic: bilirubin ≤1.5 x ULN (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP, ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.
- Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault formula.
- Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
- Signed informed consent.
- Patient compliance and geographical proximity that allow adequate follow up.
- Patients who have undergone cranial irradiation for brain metastases more than 4 weeks before inclusion in our protocol, provided that they are clinically fit to undergo second line treatment
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
- Documented brain metastases unless the patient has completed local therapy for central nervous system metastases at least 4 weeks before enrollment and has been off corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at least 4 weeks prior to enrollment is accepted.
- Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with an EGFR-TKI or docetaxel within 6 months prior to enrollment.
- Inability or unwillingness to take dexamethasone.
- Concomitant treatment with any other experimental drug under investigation.
- Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Docetaxel
Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related
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75mg/m2
다른 이름들:
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활성 비교기: Docetaxel plus erlotinib
Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related.
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75mg/m2
다른 이름들:
150mg/day
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
progression free survival
기간: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
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from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
quantitative and qualitative adverse events
기간: from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
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Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
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from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
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response rates
기간: Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
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Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
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duration of response
기간: from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
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from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
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overall survival
기간: from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
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Evaluation of overall survival (OS)
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from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Erlotinib dose level variance in blood
기간: Every six weeks from randomisation up until last treatment administration (up until 48 weeks)
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Therefore in patients on erlotinib every 6 weeks through dose levels in blood will be determined
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Every six weeks from randomisation up until last treatment administration (up until 48 weeks)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joachim G Aerts, MD PhD, Dutch Society of Physicians for Pulmonology and Tuberculosis
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 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. .
암종, 비소세포폐에 대한 임상 시험
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
Docetaxel에 대한 임상 시험
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Hebei Medical University Fourth Hospital완전한