Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15212
- NSABP Operations Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
- Evidence of adequate organ function (such as liver, kidneys, etc.)
Exclusion Criteria:
- Diagnosis of anal cancer
- Patients who are candidates for surgery
- Patients who have received previous treatments
- Pregnant or lactating women
- History of chronic disease(s) or other serious medical conditions
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 |
|---|---|
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실험적: 1
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7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
다른 이름들:
130 mg/m2 IV Day 1 every 21 days for eight cycles
다른 이름들:
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
다른 이름들:
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실험적: 2
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7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
다른 이름들:
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
다른 이름들:
200 mg/m2 IV Day 1 every 21 days for eight cycles
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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One-year Progression-free Survival (PFS)
기간: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Outcome measure was not assessed due to early study closure.
The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
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Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Objective Response Rate
기간: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Toxicity - Adverse Events
기간: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
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Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
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Overall Survival
기간: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Duration of Response
기간: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
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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
- NSABP FC-BV-003
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