- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00077298
Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
A Randomized Phase II Study of Bevacizumab in Combination With Cetuximab Plus Irinotecan, or in Combination With Cetuximab Alone, in Irinotecan-Refractory Colorectal Cancer
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Evaluate time to tumor progression in patients with irinotecan-refractory metastatic colorectal cancer treated with bevacizumab and cetuximab with or without irinotecan.
II. Evaluate objective response rate in patients treated with these regimens. III. Evaluate overall survival of patients treated with these regimens. IV. Evaluate safety, tolerability, and adverse event profiles of these regimens in these patients.
V. Correlate a panel of molecular markers (e.g., those involved in the epidermal growth factor receptor signaling pathway, angiogenic pathway, and irinotecan metabolism) with clinical outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 vs 1), and albumin (> 3.0 g/dL vs ≤ 3.0 g/dL). Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36; bevacizumab IV over 30-90 minutes on days 1*, 15, and 29 OR on days 1 and 22; and irinotecan IV over 30-90 minutes (at the same dose and schedule that the patient previously received) beginning on day 1.
ARM B: Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1*, 15, and 29.
NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses.
In both arms, courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
New York
-
New York, New York, 미국, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Histologically or cytologically confirmed colorectal cancer
- Metastatic disease by diagnostic imaging studies
Measurable disease
- At least 1 unidimensionally measurable lesion with minimum lesion size at least twice the slice thickness of the imaging study used
Refractory to irinotecan, evidenced by clinical documentation
- Received at least 1 prior irinotecan-containing chemotherapy regimen for metastatic disease and progressed during or within 6 weeks after completion of therapy
Must have received prior irinotecan according to 1 of the following schedules:
- Weekly administration with a starting dose of 100-125 mg/m^2
- Biweekly administration (every other week) with a starting dose of approximately 180 mg/m^2
- Once every three weekly administration with a starting dose of 300-350 mg/m^2
- No known brain metastases
- No prior primary CNS tumors
- Performance status - ECOG 0-1
- Performance status - Karnofsky 80-100%
- More than 3 months
- WBC >= 3,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9 g/dL
- No bleeding diathesis or coagulopathy
- Bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal (ULN) (5 times ULN in the presence of known liver metastases)
- INR < 1.5 (for patients receiving warfarin)
- Creatinine =< ULN
- Creatinine clearance ≥ 60 mL/min
- No proteinuria
- No prior stroke
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No uncontrolled hypertension
- No clinically significant cardiac arrhythmia
None of the following arterial thromboembolic events within the past 6 months:
- Myocardial infarction
- Cerebrovascular accident
- Transient ischemic attack
- Unstable angina
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No significant traumatic injury within the past 28 days
- No grade 3 or greater neurotoxicity
- No uncontrolled seizures
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents
- No prior irinotecan intolerance
- No ongoing or active infection requiring parenteral antibiotics
- No serious nonhealing active wound, ulcer, or bone fracture
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness that would preclude study participation
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No prior cetuximab
- No other prior epidermal growth factor receptor-directed therapy
No prior anticancer murine or chimeric monoclonal antibody therapy
- Prior humanized monoclonal antibody therapy allowed
- No prior bevacizumab
- No other prior vascular endothelial growth factor-targeted therapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- More than 4 weeks since prior radiotherapy
- More than 28 days since prior major surgical procedure or open biopsy
- Recovered from all prior therapy
- Any number of prior standard or investigational regimens allowed
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No recent or concurrent thrombolytic agents
- No recent or concurrent full-dose warfarin except as required to maintain patency of preexisting, permanent indwelling IV catheters
No concurrent therapeutic heparin
- Concurrent prophylactic low-molecular weight heparin allowed
- No concurrent chronic daily aspirin (> 325 mg/day)
- No concurrent nonsteroidal anti-inflammatory medications known to inhibit platelet function
- No concurrent combination antiretroviral therapy for HIV-positive patients
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 A (cetuximab, bevacizumab, irinotecan)I
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36; bevacizumab IV over 30-90 minutes on days 1*, 15, and 29 OR on days 1 and 22; and irinotecan IV over 30-90 minutes (at the same dose and schedule that the patient previously received) beginning on day 1. NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses. |
상관 연구
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
|
실험적: Arm B (cetuximab and bevacizumab)
Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1*, 15, and 29. NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses. |
상관 연구
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Time to tumor progression
기간: Date of randomization to the date of either documentation of disease progression, or death, assessed up to 3 years
|
Date of randomization to the date of either documentation of disease progression, or death, assessed up to 3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Objective response rate
기간: Up to 3 years
|
Up to 3 years
|
|
Overall survival
기간: Up to 3 years
|
Survival probabilities will be computed using Kaplan-Meier methods and compared using the log-rank test.
|
Up to 3 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Leonard Saltz, Memorial Sloan Kettering 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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCI-2012-01445 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- N01CM17101 (미국 NIH 보조금/계약)
- 03-135 (기타 식별자: Memorial Sloan-Kettering Cancer Center)
- N01CM17105 (미국 NIH 보조금/계약)
- N01CM17102 (미국 NIH 보조금/계약)
- N01CM17103 (미국 NIH 보조금/계약)
- MSKCC-03135
- NCI-6444
- CDR0000350086
- 6444 (기타 식별자: CTEP)
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. .
재발성 결장암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨생화학적으로 재발하는 전립선암 | 전이성 전립선암 | 뼈의 전이성 악성 신생물 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
실험실 바이오마커 분석에 대한 임상 시험
-
ORIOL BESTARD완전한신장 이식 | CMV 감염스페인, 벨기에
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)아직 모집하지 않음
-
Hvidovre University HospitalElsassFonden종료됨
-
Spaarne GasthuisLeiden University Medical Center모집하지 않고 적극적으로
-
Rio de Janeiro State UniversityCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento... 그리고 다른 협력자들완전한