Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor
2014년 10월 21일 업데이트: Dong Shin, Emory University
Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers
Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.
연구 개요
상세 설명
The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications.
Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.
연구 유형
중재적
등록 (실제)
17
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Winship Cancer Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Participants must have premalignant lesions.
- Lesion sites include oral cavity, oropharynx, and larynx.
- Must have at least a >20 pack-year history of smoking.
- Must have a Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1.
- Participants must be 18 years of age or older.
- No contraindications for laryngoscopy and biopsy.
- Adequate liver function.
- Must have hemoglobin and hematocrit levels at or above the lower limit of the normal range.
- Participants must have prothrombin time (PT)/partial thromboplastin time (PTT) levels at or above the lower limit of the normal range.
- Women of child-bearing potential must have a negative serum pregnancy test within 72 hours of receiving treatment.
- Must be able to swallow the oral dose of erlotinib and celecoxib.
- Participants must be disease free.
- Final eligibility will be determined by the health professionals conducting the trial.
Exclusion Criteria:
- Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
- History of previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year.
- Pregnant or breast feeding.
- Not practicing adequate contraception if the participants are of child bearing potential.
- Female patients who have a positive pregnancy test.
- History or recent myocardial infarction.
- Hypertension not adequately controlled by medication.
- Documented history of coagulopathy.
- Documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Grade II.
- Participants who were taking COX-2 inhibitors or EGFR tyrosine kinase inhibitors within 3 months of study entry.
- Documented history or interstitial lung disease.
- Known connective tissue disease.
- History of nonsteroidal antiinflammatory drug (NSAID)-induced ulcers or those who are at risk for a GI ulcer.
- Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
- Final eligibility will be determined by the health professionals conducting the trial.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Erlotinib & Celecoxib
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Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion. Celecoxib given 400 mg orally BID continuously for 6 months.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4
기간: 12 months from time of enrollment
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Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months.
Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months.
Dose escalation followed a standard 3+3 escalation design.
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12 months from time of enrollment
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Clinical Outcome: Documented Progression
기간: 12 months from time of enrollment
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Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist.
Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium.
Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia).
Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment.
Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.
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12 months from time of enrollment
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Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma
기간: Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.
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Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist.
Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium.
Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia).
Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment.
Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.
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Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Dong Shin, MD, Emory University Winship Cancer Institute
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Shin DM, Zhang H, Saba NF, Chen AY, Nannapaneni S, Amin AR, Muller S, Lewis M, Sica G, Kono S, Brandes JC, Grist WJ, Moreno-Williams R, Beitler JJ, Thomas SM, Chen Z, Shin HJ, Grandis JR, Khuri FR, Chen ZG. Chemoprevention of head and neck cancer by simultaneous blocking of epidermal growth factor receptor and cyclooxygenase-2 signaling pathways: preclinical and clinical studies. Clin Cancer Res. 2013 Mar 1;19(5):1244-56. doi: 10.1158/1078-0432.CCR-12-3149. Epub 2013 Feb 19.
- Saba NF, Hurwitz SJ, Kono SA, Yang CS, Zhao Y, Chen Z, Sica G, Muller S, Moreno-Williams R, Lewis M, Grist W, Chen AY, Moore CE, Owonikoko TK, Ramalingam S, Beitler JJ, Nannapaneni S, Shin HJ, Grandis JR, Khuri FR, Chen ZG, Shin DM. Chemoprevention of head and neck cancer with celecoxib and erlotinib: results of a phase ib and pharmacokinetic study. Cancer Prev Res (Phila). 2014 Mar;7(3):283-91. doi: 10.1158/1940-6207.CAPR-13-0215. Epub 2013 Oct 3.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 10월 1일
기본 완료 (실제)
2012년 11월 1일
연구 완료 (실제)
2012년 11월 1일
연구 등록 날짜
최초 제출
2006년 4월 11일
QC 기준을 충족하는 최초 제출
2006년 4월 11일
처음 게시됨 (추정)
2006년 4월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 10월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 10월 21일
마지막으로 확인됨
2014년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00024922
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