- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01159327
Study of Sorafenib Maintenance in Patients With ED-SCLC After Response to Induction Chemotherapy
2015년 11월 9일 업데이트: Ji-youn Han, National Cancer Center, Korea
A Randomized Phase II Study of Sorafenib Maintenance in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC) After Response to Induction Chemotherapy
A Phase I trial of weekly topotecan in combination with sorafenib in treatment of relapsed Small cell lung cancer (SCLC) has been commenced.
In the present randomized phase 2 study, the investigators will research whether Sorafenib maintenance prolongs progression free survival (PFS) and overall survival (OS) in patients with ED-SCLC who achieved CR or PR after platinum-based induction chemotherapy.
연구 개요
상세 설명
Small cell lung cancer (SCLC) comprises 10-15 % of all lung cancer.
Despite high responsiveness to initial chemotherapy, its high relapse rate makes the treatment of SCLC is challenging.
With platinum plus etoposide or irinotecan, overall response rate is as high as 85%, however, the median duration of response is short (approximately 4 months), and median survival times are 9 to 11 months, with a 2-year survival rate of less than 10% [J Clin oncology.
2009 Oct 1;27(28):4787-92].
New and more effective agents are clearly needed against SCLC.
Sorafenib is a multikinase inhibitors acting on pathways involved in tumour progression and angiogenesis, and is undergoing investigation for the treatment of SCLC in either the first- or second-line setting.
The only data available so far are on sorafenib, which seems to be a promising agent with a median survival of 7 and 5 months in platinum-sensitive and platinum-refractory patients, respectively (2008 J Clin oncology 26.
Abstract 8039).
This compared favourably with historical controls receiving salvage chemotherapy.
연구 유형
중재적
등록 (실제)
13
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, 대한민국
- National Cancer Center, Korea
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
1년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion criteria:
- Histologically or cytologically confirmed ED-SCLC patients who have achieved a complete or partial response after four to six cycles of platinum based induction chemotherapy.
- Extensive stage SCLC is defined as disease not meaning the definition of limited stage disease
- Previous radiotherapy is allowed only if < 30% of marrow bearing bones were irradiated and if radiotherapy was completed at least 2 weeks prior to enrollment and the patient has recovered from all adverse effects of prior radiotherapy.
- Age >18 years.
- Written informed consent that is consistent with ICH-GCP guidelines
- Life expectancy of greater than 3 months.
- ECOG performance status 2 (Karnofsky ≥50%).
- Ability to swallow oral medication
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and during the first 3 months after the completion of trial
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- History of cardiac disease/ HIV infection / chronic hepatitis B or C / of organ allograft
- Active clinically serious infections
- Patients with seizure disorder requiring medication or evidence or history of bleeding diathesis or coagulopathy
- Patients undergoing renal dialysis
- Pulmonary hemorrhage/ bleeding event ≥ CTCAE grade 2 within four weeks
- Any other hemorrhage/ bleeding event ≥ CTCAE grade 3 within four weeks
- Non-healing wound, ulcer or bone fracture
- Thrombotic or embolic venous or arterial events of study drug
- Previous or concurrent cancer that is distinct in histology of primary site, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated >3 years prior to entry is permitted.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Known or suspected allergy or any other contraindication for Sorafenib administration
- Pregnant or breast-feeding women.
- Any disease which could affect the evaluation of the study drug
- Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
- Any condition which could affect the absorption or pharmacokinetics of the Study drug including any type of gastrointestinal resection or surgery
- Uncontrolled symptomatic brain metastasis
Excluded therapies and medications, previous and concomitant:
- Investigational drug or device therapy including outside of this trial during or within 4 weeks prior to study entry (signing Informed Consent).
- The toxicity effects of previous antitumor chemotherapy or immunotherapy must be resolved to less than CTC Grade 2 level (exception: alopecia).
- Prior treatment with other VEGFR inhibitors (i.e. sunitinib, thalidomide, vandetanib and other experimental agents of this class).
- Major surgery within 4 weeks prior to start of study (Informed Consent signature). Minimal invasive biopsy is allowed.
- Use of biologic response modifiers, such as G-CSF, within 3 weeks prior to study entry. [Therapeutic G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction].
- Any agents which could affect the absorption or pharmacokinetics of the study drug
- Prior exposure to the study drug
- Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Prophylactic low dose warfarin (1 mg po qd) is permitted if the INR (International normalized ratio) is ≤ 1.5. Low-dose aspirin is permitted (80-100 mg daily).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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 |
---|---|
실험적: Arm A
Sorafenib maintenance arm
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Sorafenib 400mg, bid(800mg/day), daily, PO
다른 이름들:
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간섭 없음: Arm B
observation arm
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression-free survival
기간: every 8 weeks
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Progression-free survival was calculated from the randomization date until evidence of PD or death
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every 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall survival
기간: the date of registration to the date of death
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The duration of overall survival is measured from randomization date to the date of death from any cause or the last follow-up examination
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the date of registration to the date of death
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Toxicity
기간: First drug intake until 30 days after last treatment admisitration
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For grading of adverse events CTCAE criteria (version 4.0) will be utilized.
All adverse events occurring between first drug intake until 30 days after last treatment administration will be reported.
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First drug intake until 30 days after last treatment admisitration
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 12월 1일
기본 완료 (실제)
2013년 4월 1일
연구 완료 (실제)
2013년 6월 1일
연구 등록 날짜
최초 제출
2010년 7월 8일
QC 기준을 충족하는 최초 제출
2010년 7월 8일
처음 게시됨 (추정)
2010년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 11월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 11월 9일
마지막으로 확인됨
2015년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCCCTS-10-476
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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