- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00070122
Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer
A Phase III Trial of Modified FOLFOX6 Versus CAPOX, With Bevacizumab (NSC-704865) or Placebo, as First-Line Therapy in Patients With Previously Untreated Advanced Colorectal Cancer
연구 개요
상태
상세 설명
OBJECTIVES:
I. Compare overall survival in patients with locally advanced, metastatic, or recurrent colorectal cancer treated with fluorouracil, leucovorin calcium, oxaliplatin, and bevacizumab vs capecitabine, oxaliplatin, and bevacizumab.
II. Compare progression-free survival and time to treatment failure in patients treated with these regimens.
III. Compare the response of patients with measurable disease treated with these regimens.
IV.Compare toxicity rates of these regimens in these patients. V. Compare patient-reported functional status and convenience of therapy in patients treated with these regimens.
VI. Correlate germline polymorphisms of DNA repair (e.g., ERCC-1, XRCC1, GST-P1, XPD, and ribonucleotide reductase), target enzymes (e.g., thymidylate synthase, dihydropyrimidine dehydrogenase, and thymidine phosphorylase), angiogenesis (e.g., vascular endothelial growth factor), and growth factors (e.g., epithelial growth factor receptor) with survival, progression-free survival, and toxicity from chemotherapy in patients treated with these regimens.
VII. Correlate tumor mRNA expression levels of similar DNA repair enzymes as well as enzymes involved in angiogenesis with survival and progression-free survival in patients treated with these regimens.Correlate tumor mRNA expression levels of similar target enzymes before treatment with survival, progression-free survival, and toxicity in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 or 1 vs 2) and prior adjuvant therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients are further randomized to receive bevacizumab or placebo* IV over 30-90 minutes on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
ARM II: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine on days 1-15. Patients are further randomized to receive bevacizumab or placebo* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
Patients are followed every 3 months until disease progression. After disease progression, patients are followed every 6 months for 2 years and then annually for up to 4 years after study entry.
PROJECTED ACCRUAL: A total of 2,200 patients (1,100 per treatment arm) will be accrued for this study within 3 years.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Texas
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San Antonio, Texas, 미국, 78245
- Southwest Oncology Group
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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 locally advanced, recurrent, or metastatic colorectal adenocarcinoma
- Not curable by surgery or amenable to radiotherapy with curative intent
Previously resected colorectal cancer with new evidence of metastasis does not require separate histologic or cytologic confirmation unless one of the following is true:
- More than 5 years has elapsed between primary surgery and development of metastatic disease
- Primary tumor was T1-T2, N0, M0
- Site of primary lesion must be or have been in the large bowel as determined by endoscopy, radiology, or surgery
- Measurable or evaluable disease
- No known brain or leptomeningeal disease
- Performance status - Zubrod 0-2
- No history of hemorrhagic or thrombotic disorders
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Bilirubin no greater than 2.0 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN (5 times ULN for patients with liver involvement)
- Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN for patients with liver involvement or 10 times ULN for patients with bone involvement)
- INR no greater than 1.5
- PTT no greater than ULN
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 50 mL/min
- Proteinuria less than 1+*
- Protein less than 500mg/24 hours*
No uncontrolled hypertension
- Hypertension must be well-controlled (i.e., less than 160/90) and on a stable regimen of antihypertensive therapy
- No unstable angina
- No symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No serious uncontrolled cardiac arrhythmia
- No New York Heart Association class III or IV heart disease
- No symptomatic pulmonary fibrosis
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
- No active or uncontrolled severe infection
No contraindication to oral medications (e.g., severe dysphagia)
- G-tubes or J-tubes allowed
- No peripheral neuropathy greater than grade 1
- No serious non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No other severe acute or chronic medical condition or laboratory abnormality that would preclude study participation
- No psychiatric condition that would preclude study participation
- No prior bevacizumab
- No prior oxaliplatin
No prior chemotherapy for advanced colorectal cancer
- Prior adjuvant therapy for resected stage II-III disease allowed provided at least 12 months have elapsed between completion of therapy and diagnosis of recurrent disease
- At least 28 days since prior radiotherapy and recovered
- See Disease Characteristics
- More than 28 days since prior major surgical procedure or open biopsy
- More than 7 days since prior fine needle aspiration or core biopsy
- No concurrent major surgery
- More than 10 days since prior full-dose aspirin (325 mg)
- No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol)
- No other concurrent investigational agents
No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation of central venous lines allowed
- Low-dose prophylactic enoxaparin or heparin allowed
- No concurrent cimetidine
- No concurrent sorivudine or its related analogs (e.g., brivudine)
- No concurrent use of a cold cap or iced mouth rinses
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Arm I (oxaliplatin, leucovorin calcium, fluorouracil)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1.
Patients are further randomized to receive bevacizumab or placebo* IV over 30-90 minutes on day 1.
Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
|
상관 연구
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
|
실험적: Arm II (oxaliplatin, capecitabine)
Patients receive oxaliplatin IV over 2 hours on day 1and oral capecitabine on days 1-15.
Patients are further randomized to receive bevacizumab or placebo* as in arm I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
|
상관 연구
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
구두로 주어진
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall survival in patients with colorectal cancer treated with fluorouracil/leucovorin calcium and oxaliplatin with and without becavizumab versus those treated with capecitabine and oxaliplatin with our without bevacizumab
기간: Up to 6 years
|
Will be analyzed primarily by the stratified Cox model.
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Up to 6 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time to treatment failure
기간: Up to 6 years
|
Will be analyzed primarily by the Cox stratified model.
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Up to 6 years
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Progression-free survival
기간: Up to 6 years
|
Will be analyzed primarily by the Cox stratified model.
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Up to 6 years
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Response (among patients with measurable disease)
기간: Up to 6 years
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Will be analyzed primarily by the Cox stratified model.
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Up to 6 years
|
Treatment toxicities graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0)
기간: Up to the time of progression
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Up to the time of progression
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Change in FACT-C TOI
기간: Baseline to 25 weeks
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The analysis for evaluating this change will be a comparison of the change score between the first and last assessment.
If cohort patterns for mean scores do not show signs of informative missing data, a mixed effects linear model approach will be used to measure change in FACT-C TOI scores.
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Baseline to 25 weeks
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Change in Chemotherapy Convenience and Satisfaction Questionnaire scores
기간: Baseline to 25 weeks
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Effect size will be used to compare the size of the difference in each arm.
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Baseline to 25 weeks
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Whether gene expression variables are predictive of survival and progression-free survival
기간: Up to 6 years
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Up to 6 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Charles Blanke, Southwest Oncology Group
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
- 소화기계 질환
- 병리학적 과정
- 조직학적 유형에 따른 신생물
- 신생물
- 부위별 신생물
- 암종
- 신생물, 선상 및 상피
- 질병 속성
- 위장관 신생물
- 소화계 신생물
- 위장병
- 결장 질환
- 장 질환
- 장 신생물
- 직장 질환
- 대장 신생물
- 회귀
- 선암종
- 직장 신생물
- 대장 신생물
- 약물의 생리적 효과
- 약리작용의 분자기전
- 항대사물질, 항종양
- 항대사물질
- 항종양제
- 면역억제제
- 면역학적 요인
- 보호제
- 혈관신생 억제제
- 혈관신생 조절제
- 성장 물질
- 성장 억제제
- 미량 영양소
- 비타민
- 해독제
- 비타민 B 복합체
- 항체
- 플루오로우라실
- 카페시타빈
- 옥살리플라틴
- 면역글로불린
- 베바시주맙
- 류코보린
- 레볼류코보린
- 항체, 단클론
- 항종양제, 면역학적
기타 연구 ID 번호
- NCI-2012-02556
- U10CA032102 (미국 NIH 보조금/계약)
- S0303
- CDR0000330000 (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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