- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00047333
Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To assess progression-free survival (PFS) measured at 16 weeks following initiation of once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular carcinoma.
SECONDARY OBJECTIVES:
I. To assess objective response rate, rate and duration of stable disease, time to progression, median and overall survival in this patient population, and any changes in tumor perfusion based on functional CT imaging.
II. To correlate response with patient characteristics including: age, disease stage (TNM, Okuda [6]), viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, Performance Status, serum values of: alpha feto-protein, bilirubin, transaminases, albumin; EGFR expression score by IHC; and development of skin rash during therapy.
III. To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient population.
IV. To determine the safety and tolerability of OSI-774 in this patient population.
OUTLINE: Patients are stratified according to epidermal growth factor receptor expression (low, 0-1+ vs high, 2-3+).
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection
- No fibrolamellar HCC
No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents
The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study
- Surgery
- Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection)
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- Must have paraffin tissue block or unstained slides from biopsy or surgical specimen
- No known brain metastases
- No ascites that are refractory to conservative management (e.g., sodium restriction to 50 mEq/day dietary sodium and fluid restrictions and/or diuretics)
- Performance status - ECOG 0-2
- At least 16 weeks
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 60,000/mm^3
- Hemoglobin at least 10 g/dL
- Bilirubin no greater than 1.8 mg/dL
- Albumin at least 2.5 g/dL
- AST/ALT no greater than 5 times upper limit of normal
- PT no greater than 1-3 seconds over normal
- No decompensated liver disease
- No jaundice
- No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius)
- No hyponatremia with sodium less than 125 mEq/L
- No portal hypertension with bleeding esophageal or gastric varices within the past 3 months
- Creatinine no greater than 2 mg/dL
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation
- No active peptic ulcer disease
- No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No other uncontrolled concurrent illness that would preclude study participation
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior surgical therapy affecting absorption
- More than 30 days since prior investigational agents
- No concurrent commercial or other investigational anticancer agents or therapies
- No concurrent combination antiretroviral therapy for HIV-positive patients
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 |
---|---|
실험적: Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
상관 연구
상관 연구
다른 이름들:
주어진 PO
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression-free survival
기간: Time from initiation of therapy until documented disease progression, assessed at 16 weeks
|
Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.
|
Time from initiation of therapy until documented disease progression, assessed at 16 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Objective response rate
기간: Up to 4 years
|
Summarized by estimates and standard errors.
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Up to 4 years
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Rate of stable disease
기간: Up to 4 years
|
Summarized by estimates and standard errors.
|
Up to 4 years
|
Duration of stable disease
기간: From the start of the treatment until the criteria for progression are met, assessed up to 4 years
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Summarized by Kaplan-Meier curves, from which medians and overall duration of stable disease can be attained.
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From the start of the treatment until the criteria for progression are met, assessed up to 4 years
|
Time to progression
기간: Up to 4 years
|
Summarized by Kaplan-Meier curves, from which medians and time to progression can be attained.
|
Up to 4 years
|
Overall survival
기간: Up to 4 years
|
Summarized by Kaplan-Meier curves, from which medians and overall survival can be attained.
|
Up to 4 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Melanie Thomas, M.D. Anderson Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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-2012-02498
- ID02-008
- CDR0000257665 (레지스트리 식별자: PDQ (Physician Data Query))
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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