FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
2015년 5월 7일 업데이트: SCRI Development Innovations, LLC
A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection, in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.
연구 개요
상태
완전한
정황
상세 설명
Further data has emerged showing a consistent lack of efficacy using EGFR inhibitor panitumumab in combination with chemotherapy in the treatment of patients with KRAS mutant colorectal cancer.
For patients with liver-only metastatic colorectal cancer, improvement in response rates with newer chemotherapy regimens has led to a larger percentage of patients eligible for surgical resection.
Treatment with FOLFOXIRI improves response rates when compared to FOLFIRI.
Similarly, the addition of an EGFR inhibitor improves the response rate of FOLFIRI in patients with wild-type KRAS.
In this trial, we will attempt to maximize the response rate and the surgical resection rate by using FOLFOXIRI and panitumumab.
연구 유형
중재적
등록 (실제)
15
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arkansas
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Jonesboro, Arkansas, 미국, 72401
- NEA Baptist Clinic
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Florida
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Ft. Myers, Florida, 미국, 33916
- Florida Cancer Specialists
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Orlando, Florida, 미국, 32804
- Florida Hospital Cancer Institute
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St. Petersburg, Florida, 미국, 33705
- Florida Cancer Specialists
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Georgia
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Gainesville, Georgia, 미국, 30501
- Northeast Georgia Medical Center
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Indiana
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Terre Haute, Indiana, 미국, 47802
- Providence Medical Group
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Terre Haute, Indiana, 미국, 47802
- Hope Cancer Center
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Maryland
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Bethesda, Maryland, 미국, 20817
- Center for Cancer and Blood Disorders
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New Hampshire
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Portsmouth, New Hampshire, 미국, 03801
- Portsmouth Regional Hospital
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New Jersey
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Morristown, New Jersey, 미국, 07960
- Hematology-Oncology Associates of Northern NJ
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Ohio
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Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care, Inc
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Chattanooga Oncology Hematology Associates
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Collierville, Tennessee, 미국, 38017
- Family Cancer Center
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology, PLLC
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Texas
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Fort Worth, Texas, 미국, 76104
- The Center for Cancer and Blood Disorders
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patient must have a biopsy confirmed adenocarcinoma of the colon or rectum with stage IV (metastatic) liver-only disease, as defined by staging with CT scans.
- Patients must have a baseline evaluation to determine whether liver metastases are resectable (e.g. a single liver metastasis in a resectable location)or unresectable (surgical consultation is recommended). Both groups are eligible for this study.
- Tumor tissue must reveal wild-type KRAS expression (i.e. no KRAS mutation) prior to study entry (see Section 7.4.4.).
- Patients must have at least one unidimensional measurable lesion definable by CT scan. Disease must be measurable per RECIST version 1.1 criteria (see Section 9).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix A).
Laboratory values as follows:
ANC greater than 1500/μL
Hgb greater than9 g/dL
Platelets greater than 100,000/μL
AST/SGOT less than 5.0 x ULN
ALT/SGPT less than or equal to 5.0 x ULN
Alk Phos less than or equal to 5.0 x ULN
Bilirubin less than or equal to 1.5 x ULN
Creatinine 1.5 mg/dL or calculated creatinine clearance 50 ml/min
Magnesium LLN
- Patient must have a life expectancy of greater than 12 weeks.
- Patient must be greater than or equal to 18 years of age.
- Patient must be accessible for treatment and follow-up.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed less than or equal to 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- Patient must be able to understand the nature of the study and give written informed consent prior to study entry.
Exclusion Criteria:
- Prior systemic therapy for metastatic colorectal cancer (including chemotherapy, bevacizumab, cetuximab, panitumumab, and other targeted agents).
- Adjuvant chemotherapy (and/or chemoradiation) for colorectal carcinoma ending less than or equal to 12 months prior to the diagnosis of metastatic cancer. Prior radiation therapy (in the metastatic setting) may be allowed if it was completed greater than or equal to 4 weeks prior to enrollment and measurable lesions are outside the radiation portal site.
- Any detectable metastases in areas other than the liver.
- Known liver disease or other significant medical illness that would exclude the patient as a candidate for resection of liver metastases.
- Patients requiring therapeutic coumadin or heparin (for a history of pulmonary emboli or deep vein thrombosis [DVT]) will be excluded.
- Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury less than or equal to 4 weeks prior to beginning treatment.
- History of Gilbert's disease.
- History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, irinotecan, panitumumab, and/or oxaliplatin), or known dipyrimidine dehydrogenase (DPD) deficiency
- Serious cardiac arrhythmia requiring medication.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, an infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus or acute or chronic hepatitis B infection.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Use of any non-approved or investigational agent less than or equal to 28 days prior to administration of the first dose of study drug.
- Past or current history of neoplasm other than the entry diagnosis with the exception of treated non melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS greater than or equal to 5 years.
- Patients with National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE) Grade 2 peripheral neuropathy.
- Female patients who are pregnant or lactating.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: FOLFOXIRI+panitumumab regimen
All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
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6 mg/kg, 60-90 minute IV infusion every 2 weeks
다른 이름들:
85 mg/m2, 2-hour IV infusion every 2 weeks
다른 이름들:
125 mg/m2, 1-hour IV infusion every 2 weeks
다른 이름들:
200 mg/m2, 2-hour IV infusion every 2 weeks
다른 이름들:
3200 mg/m2 IV, 48-hour continuous infusion every two weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Response Rate (ORR)
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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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 Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their 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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R0 Resection Rate
기간: 18 months
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To determine the rate of complete (R0) resection for patients treated with this regimen.
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18 months
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To Determine the Acute Toxicity Produced by This Regimen.
기간: 18 months
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The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.
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18 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 연구 의자: Johanna Bendell, MD, SCRI Development Innovations, LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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
2010년 12월 1일
기본 완료 (실제)
2014년 3월 1일
연구 완료 (실제)
2014년 3월 1일
연구 등록 날짜
최초 제출
2010년 10월 15일
QC 기준을 충족하는 최초 제출
2010년 10월 20일
처음 게시됨 (추정)
2010년 10월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 7일
마지막으로 확인됨
2015년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SCRI GI 134
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