- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01769508
Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer
A Phase II Study With Lead-in Safety Cohort of 5-Fluorouracil, Oxaliplatin and Lapatinib in Combination With Radiation Therapy as Neoadjuvant Treatment for Patients With Localized HER2 Positive Esophagogastric Adenocarcinomas
연구 개요
상태
상세 설명
This is an open-label, non-randomized, Phase II study with a lead-in safety cohort. The study will evaluate the combination of 5-Fluorouracil, Oxaliplatin and Lapatinib with radiation therapy as neoadjuvant treatment for patients with previously untreated localized HER2 positive esophagogastric adenocarcinomas. Approximately 12 patients will be enrolled in the lead-in cohort to evaluate the safety of the combination. Following the lead-in cohort, Phase II will commence and up to 30 additional patients may be treated. The starting doses will be administered as follows:
5-FU 225 mg/mg2 continuous intravenous (IV) infusion Days 1 - 42 during XRT; Oxaliplatin 85 mg/m2 Days 1, 15 and 29, given by IV infusion, per institutional standard; Lapatinib Continuous PO daily dosing during XRT (final dose determined during lead-in cohort).
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Florida
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Fort Myers, Florida, 미국, 33916
- Florida Cancer Specialists - South
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Orlando, Florida, 미국, 32804
- Florida Hospital Cancer Institute
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Pensacola, Florida, 미국, 32503
- Woodlands Medical Specialists
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St. Petersburg, Florida, 미국, 33705
- Florida Cancer Specialists-North
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Georgia
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Gainesville, Georgia, 미국, 30501
- Northeast Georgia Medical Center
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Michigan
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Grand Rapids, Michigan, 미국, 49503
- Grand Rapids Oncology Program
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Ohio
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Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Chattanooga Oncology and Hematology Associates
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed Stage I, II, or III adenocarcinoma of the esophagus (lower ⅓), GE junction, or gastric cardia.
- Clinical stage I, II, or III as assessed by required baseline staging. In addition, patients with celiac node involvement (stage IVa) are eligible.
- Patients must be surgical candidates based on stage and location of disease as well as other medical conditions and risk factors.
- Positive HER2 status (overexpression and/or amplification of HER2 in primary tumor) as defined by FISH (HER2 FISH positivity).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- Patient must be able to swallow and absorb oral medication.
- Patients must have an indwelling central venous access catheter.
- Adequate hematologic, renal, and hepatic function:
- Known brain or leptomeningeal metastases.
- Male patients willing to use adequate contraceptive measures.
- Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of treatment.
- Life expectancy ≥ 12 weeks.
- Age ≥18 years of age.
- Willingness and ability to comply with trial and follow-up procedures.
- Ability to understand the nature of this trial and give written informed consent.
Exclusion Criteria:
- Patients with evidence of distant metastases are ineligible, as are patients who are not potential surgical candidates based on location or extent of local disease. Patients with celiac nodal disease (Stage IVa) will be allowed on study.
- Previous anti-cancer treatment for esophageal, GE junction, or gastric cancer.
- Any other investigational agents within the 28 days prior to day 1 of the study.
- Known active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
- Concurrent treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A that cannot be discontinued or switched to different medication prior to starting study drug.
- Concurrent use of St. John's wort and grapefruit /grapefruit juice ≤7 days prior to starting study drug is not allowed.
- Ongoing treatment with full-dose warfarin or its equivalent. Prophylactic treatment with 1 mg daily of warfarin and/or low molecular weight heparin is allowed.
- History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of a novel regimen, or that might affect interpretation of the results of this study or render the subject at high-risk for treatment complications.
- Active gastrointestinal (GI) disease or other condition that in the opinion of the investigator will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, or vomiting).
- Poorly controlled or clinically significant atherosclerotic vascular disease
- A serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).
- Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
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 |
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실험적: Combined Therapy
Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery
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5-FU, 225 mg/m2 IVCI, during XRT.
다른 이름들:
Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
다른 이름들:
Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
다른 이름들:
Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pathologic Complete Response Rate (pCR Rate)
기간: 18 months
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Defined as the absence of invasive tumor in esophagogastric and lymph node tissue removed at time of surgery, as judged by the local pathologist.
An improvement in pCR rate from 30 percent (historical) to 50 percent is the primary efficacy endpoint.
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18 months
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Safety and Optimal Dose of Regimen
기간: 18 months
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An additional primary objective is to evaluate the safety and optimal dose of lapatinib when added to 5-FU, oxaliplatin and radiation therapy.
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18 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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전체 생존(OS)
기간: 18개월
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환자가 프로토콜 치료의 첫 번째 날짜부터 사망할 때까지 생존한 기간(월)
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18개월
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Progression Free Survival (PFS)
기간: 18 months
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The Percentage of Patients Who Experience an Objective Benefit From Treatment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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18 months
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Toxicity Profile for Treated Patients
기간: 18 months
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Defined as the frequency of adverse events for patients who received at least one dose of study treatment, and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
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18 months
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Time to Progression (TTP)
기간: 18 months
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Time to progression is defined as the time between day 1 cycle 1 and time to first documented disease progression.
Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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18 months
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Johanna C Bendell, MD, SCRI Development Innovations, LLC
간행물 및 유용한 링크
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
- SCRI GI 166
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5-Fluorouracil에 대한 임상 시험
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Hong Kong Nasopharyngeal Cancer Study Group LimitedThe Hong Kong Anti-Cancer Society; hong Kong Cancer Fund완전한
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ClinAssessSanofi; Merck Sharp & Dohme LLC완전한
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Encube Ethicals Pvt. Ltd.CBCC Global Research완전한
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Gruppo Oncologico del Nord-OvestSeagen Inc.; Servier; Foundation Medicine모병II기 결장암 | 3기 결장암 | HER2 양성 대장암 | RAS 야생형 결장암이탈리아
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National Institute of Public Health, CambodiaEmory University; World Vision International; World Vision, Hong Kong; World Vision, Cambodia완전한
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Taipei Medical University Shuang Ho Hospital완전한