- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00881751
Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer
A Randomized Open-Label Multi-Institution Phase II Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab, erlotinib, and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab together with erlotinib is more effective than giving sorafenib in treating patients with liver cancer.
PURPOSE: This randomized phase II trial is studying how well giving bevacizumab together with erlotinib works compared with sorafenib as first-line therapy in treating patients with advanced liver cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- To estimate the overall survival in patients with advanced hepatocellular carcinoma treated with bevacizumab and erlotinib hydrochloride vs sorafenib tosylate.
Secondary
- To estimate the event-free survival and tumor response rate of these patients.
- To evaluate the safety and tolerability of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.
- Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and then every 3 months for 1 year.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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San Francisco, California, 미국, 94115
- California Pacific Medical Center
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New York
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New York, New York, 미국, 10032
- Columbia University/ New York Presbyterian Hospital
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology, PLLCat Sarah Cannon Cancer Center
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Virginia
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Charlottesville, Virginia, 미국, 22908
- UVA Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Pathologically confirmed advanced hepatocellular carcinoma (HCC)
- Childs-Pugh class A
- CLIP score ≤ 5
- Not a candidate for curative surgical resection or loco-regional therapy
Measurable disease as per RECIST 1.1 criteria, defined as ≥ 1 previously unirradiated, bidimensionally measurable lesion ≥ 20 mm by CT scan or MRI (triphasic spiral CT scan or MRI employing a "liver protocol" image capture technique required)
- Bone lesions, ascites, and pleural effusions are not considered measurable lesions
- No fibrolamellar HCC
- No known brain metastases
- No prior organ transplantation
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 9 g/dL
- Transaminases ≤ 5 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 times ULN
PT ≤ 1.8 times ULN
- Prolonged INR allowed for patients who require full dose anticoagulation
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 45 mL/min
- Urine protein < 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 weeks after completion of study treatment
- Able to take and absorb oral medication
- No active infection requiring parenteral therapy
- No known HIV or AIDS
- No uncontrolled blood pressure (BP), defined as systolic BP ≥ 150 mm Hg and/or diastolic BP ≥ 100 mm Hg
No uncontrolled or significant cardiovascular disease, including any of the following:
- Myocardial infarction within the past 6 months
- Uncontrolled angina within the past 6 months
- New York Heart Association class II-IV congestive heart failure
- Grade 3 cardiac valve dysfunction
- Cardiac arrhythmia not controlled by medication
- Stroke or transient ischemic attack within the past 6 months
- Arterial thrombotic event of any type within the past 6 months
- No significant or symptomatic vascular disease (e.g., aortic aneurysm, aortic dissection, or peripheral vascular disease) within the past 6 months
- No decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy not corrected by conservative measures
No grade 3 bleeding esophageal or gastric varices within the past 2 months
- Prior variceal bleeding allowed provided patient has undergone banding or sclerotherapy and there has been no evidence of bleeding for 2 months
- No gastric varices ≥ grade 2
- No hemoptysis (i.e., ≥ ½ teaspoon of bright red blood per episode) within the past month
- No evidence of bleeding diathesis or coagulopathy
- No concurrent uncontrolled illness, including, but not limited to, a history of or current evidence of unexplained nephrotic syndrome or other severe illness/disease that would preclude study participation
- No history of hypertensive crisis or hypertensive encephalopathy
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious, non-healing wound, active ulcer, or untreated bone fracture
- No significant traumatic injury within the past 28 days
- No history of allergy to bevacizumab, erlotinib hydrochloride, sorafenib tosylate, or related compounds
- No other primary malignancy within the past 5 years, except carcinoma in situ of the cervix or urinary bladder or nonmelanoma skin cancer
- No mental incapacitation or psychiatric illness that would preclude study participation
- Not incarcerated or compulsorily detained (i.e., involuntarily incarcerated) for treatment of either a psychiatric or physical illness (e.g., infectious disease)
PRIOR CONCURRENT THERAPY:
- Prior surgery, local ablation, trans-arterial hepatic artery embolization, or trans-arterial chemoembolization are allowed provided the lesion(s) have progressed since treatment OR there are additional measurable, untreated lesions present
- No prior systemic therapy for HCC
- No prior organ transplantation
- More than 7 days since prior minor surgical procedures, fine needle aspirations, or core biopsies (excluding placement of a vascular access device)
- More than 28 days since any prior therapy
- More than 28 days since prior and no concurrent major surgical procedure or open biopsy
- More than 28 days since prior and no concurrent participation in another experimental drug study
- No other concurrent anticancer or antitumor therapy, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
- No other concurrent investigational agents
- No concurrent warfarin (other types of anticoagulation allowed)
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 |
---|---|
실험적: Arm 1: bevacizumab and erlotinib
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.
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주어진 IV
구두로 주어진
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활성 비교기: Arm 2: sorafenib tosylate
Patients receive oral sorafenib tosylate twice daily on days 1-28.
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구두로 주어진
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall Survival
기간: from date of day 1 until the date of death
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Overall survival is defined as the time from treatment day 1 until death from any cause.
Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.
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from date of day 1 until the date of death
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Event-free Survival
기간: From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.
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EFS is defined as the time from randomization to any of the following three types of events: 1 - progression; 2 - withdrawal due to excessive toxicity; 3 - any other clinical event requiring withdrawal from the study.
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From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.
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Number of SAEs Experienced
기간: From day 1 of drug administration until 30 days after the last dose of study drug.
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The study will report the number of SAEs experienced in each arm.
All patients who receive any study drug will be evaluable for toxicity.
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From day 1 of drug administration until 30 days after the last dose of study drug.
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Response Rate
기간: From day 1 drug administration until 30 days after the last dose of study drug.
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Secondary outcome measures include response rate as assessed on restaging imaging studies utilizing RECIST 1.1.
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From day 1 drug administration until 30 days after the last dose of study drug.
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공동 작업자 및 조사자
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
- 101282
- MUSC-101282
- GENENTECH-AVF4481s
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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