- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00336960
Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery
Phase II Pilot Study of Pre-Operative Celecoxib (Celebrex) in Combination With Prolonged Venous Infusion 5FU and Radiation Therapy for Patients With Stage II/III Resectable Rectal Cancer
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil and radiation therapy works in treating patients with stage II or stage III rectal cancer that can be removed by surgery.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Determine cyclo-oxygenase-2 (COX-2) overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib, fluorouracil, and radiotherapy.
- Determine whether administration of celecoxib, a COX-2 inhibitor, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in the surrounding normal tissue.
- Determine if there is a greater change in protein and gene expression in post-treatment biopsies when compared to pretreatment biopsies that are greater for tumor (COX-2 overexpression) than in surrounding normal tissue.
- Determine whether patients who express the greatest degree of change in gene and protein expression are those most likely to respond to therapy.
- Assess the toxicities of concurrent treatment with celecoxib, fluorouracil, and radiotherapy.
OUTLINE: This is a pilot study.
Patients receive oral celecoxib twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive concurrent fluorouracil IV continuously for 5 weeks. Patients undergo radical resection 4-10 weeks after completion of chemoradiotherapy.
Patients undergo tumor biopsy at baseline and then at the time of surgical resection. Patients also undergo blood and urine collection at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. The specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37212
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
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Nashville, Tennessee, 미국, 37232-5671
- Vanderbilt-Ingram Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the rectum
- Stage II or III disease
Distal border of tumor must be at or below the peritoneal reflection
- Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam
- Tumor must be clinically resectable
- Transmural penetration beyond muscularis propria by transrectal ultrasound
- No high-grade obstruction
- No evidence of metastatic disease
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- WBC ≥ 4,000/mm³
- Platelet count ≥ 150,000/mm³
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious medical illness or psychiatric condition that would preclude study treatment
- No history of allergy to celecoxib or any other NSAIDs
- No history of allergy to sulfonamides
- No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the pelvis
- At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs)
- No concurrent warfarin except low-dose warfarin (1 mg/day)
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 intervention
|
twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy
Patients receive concurrent fluorouracil IV continuously for 5 weeks.
4-10 weeks after completion of chemoradiotherapy
Patients undergo radiotherapy 5 days a week for 5 weeks
at baseline and then at the time of surgical resection
blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection.
specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Pathologic complete response rate
기간: at time of surgery, day 5
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at time of surgery, day 5
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Complete resection rate
기간: at time of surgery, day 5
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at time of surgery, day 5
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Patterns of failure
기간: during study, beginning day 5 forward
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during study, beginning day 5 forward
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Survival
기간: at time of death
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at time of death
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Toxicity
기간: 5 days before surgery & 5 days after surgery
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5 days before surgery & 5 days after surgery
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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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VICC GI 0173
- P30CA068485 (미국 NIH 보조금/계약)
- P50CA095103 (미국 NIH 보조금/계약)
- VICC-GI-0173
- VICC-020031
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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