Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
2015년 11월 24일 업데이트: Eli Lilly and Company
Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study
The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.
연구 개요
연구 유형
중재적
등록 (실제)
72
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Arizona
-
Casa Grande, Arizona, 미국, 85122
- Donald W. Hill M.D., P.C.
-
-
California
-
Beverly Hills, California, 미국, 90211
- Beverly Hills Cancer Center
-
Los Angeles, California, 미국, 90036
- Cancer Care Institute
-
Oakland, California, 미국, 94609
- Northern California Hematology & Oncology
-
San Diego, California, 미국, 92123
- Sharp Clinical Oncology Research
-
-
Florida
-
Ft. Lauderdale, Florida, 미국, 33308
- Broward Oncology Associates, P.A.
-
Miami, Florida, 미국, 33125
- Elite Research Institute
-
-
Illinois
-
Skokie, Illinois, 미국, 60076
- Edward H. Kaplan, MD & Associates
-
-
Minnesota
-
Edina, Minnesota, 미국, 55435
- Fairview Southdale Medical Oncology Clinic
-
-
North Dakota
-
Bismarck, North Dakota, 미국, 58501
- Mid Dakota Clinic, PC
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19140
- Temple University Hospital
-
-
Texas
-
Lubbock, Texas, 미국, 79415
- University Medical Center
-
-
Washington
-
Kennewick, Washington, 미국, 99336
- Columbia Basin Hematology and Oncology
-
-
-
-
New Brunswick
-
Moncton, New Brunswick, 캐나다, E1C 6Z8
- The Moncton Hospital
-
-
Newfoundland and Labrador
-
Grand Falls-Windsor, Newfoundland and Labrador, 캐나다, A2A 2E2
- Local Institution
-
-
Ontario
-
Mississauga, Ontario, 캐나다, L5M 2N1
- The Credit Valley Hospital
-
Sudbury, Ontario, 캐나다, P3E 5J1
- Sudbury Regional Hospital
-
Thunder Bay, Ontario, 캐나다, P7B 6V4
- Thunder Bay Regional Health Sciences Centre (Regional Cancer Care)
-
Toronto, Ontario, 캐나다, M4C 3E7
- Toronto East General Hospital
-
-
Quebec
-
Rimouski, Quebec, 캐나다, G5L 5T1
- Centre De Sante Et De Services Sociaux De Rimouski-Neigette
-
-
-
-
-
Ponce, 푸에르토 리코, 00716
- Ponce School of Medicine (Caimed Center)
-
San Juan, 푸에르토 리코, 00927
- Fundacion De Investigacion de Diego
-
-
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:
- Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
- Evaluable or measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
- Uncontrolled Central Nervous System (CNS) metastasis.
- Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
- Concurrent malignancy
- Prior chemotherapy for NSCLC
- Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
- Superior vena cava syndrome contra-indicating hydration
- White Blood Cells (WBC) < 3,000/mm³
- Absolute neutrophile count (ANC) < 1,500/mm³
- Platelet < 100,000/mm³
- Hemoglobin (Hgb) < 9.0 g/dL
- Total bilirubin > 1.5 x Upper limit of normal (ULN).
- Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) > 5.0 x ULN.
- Serum creatinine >1.25 x ULN and calculated creatinine clearance <60mL/min
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 |
|---|---|
|
실험적: Cetuximab + Cisplatin + Vinorelbine
|
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
다른 이름들:
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
다른 이름들:
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
기간: Day 1 up to 30 days after last dose
|
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
MedDRA version 14.0.
Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
|
Day 1 up to 30 days after last dose
|
|
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
기간: Day 1 to 30 days after last dose
|
Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events.
Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0).
Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less.
Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
|
Day 1 to 30 days after last dose
|
|
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
기간: Day 1 up to 30 days after last dose
|
ULN=Upper limit of normal among all laboratory ranges.
ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase.
CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN.
AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN.
Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN.
Albumin (low) Grade 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Grade 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Grade 3: < 2 g/dL to <2 g/L.
Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
|
Day 1 up to 30 days after last dose
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
기간: Day 2 up to 30 days after last dose
|
Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug.
WBC normal range: 4.1-12.3
x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36
x 10^9/μL.
|
Day 2 up to 30 days after last dose
|
|
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
기간: Day 1 up to 30 days after last dose
|
ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal.
CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 - 155 mmol/L; Gr 3: >155 - 160mmol/L; Gr 4: >160 mmol/L.
Sodium low(L) Gr 1:<LLN - 130mmol/L; Gr 3: <130 - 120 mmol/L; Gr 4: <120 mmol/L.
Potassium (H) Gr 1: >ULN - 5.5 mmol/L; Gr 2: >5.5 - 6.0 mmol/L; Gr 3: > 6.0 - 7.0 mmol/L; Gr 4: >7.0 mmol/L.
Potassium (L) Gr 1: <LLN - 3.0 mmol/L; Gr 2: <LLN - 3.0 mmol/L; Gr 3: < 3.0 - 2.5 mmol/L; Gr 4: <2.5 mmol/L.
Serum creatinine (H) Gr 1: >1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN.
Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
|
Day 1 up to 30 days after last dose
|
|
Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
기간: Day 1 up to 30 days after last dose
|
Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
MedDRA version 14.0.
Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
|
Day 1 up to 30 days after last dose
|
|
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
기간: Day 1 up to 30 days after last dose
|
Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship.
Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events.
Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0).
Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less.
Day 1=start of study drug; to 30 days after last dose of any treatment.
|
Day 1 up to 30 days after last dose
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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 7월 1일
기본 완료 (실제)
2012년 9월 1일
연구 완료 (실제)
2012년 9월 1일
연구 등록 날짜
최초 제출
2010년 4월 22일
QC 기준을 충족하는 최초 제출
2010년 4월 22일
처음 게시됨 (추정)
2010년 4월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 12월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 11월 24일
마지막으로 확인됨
2015년 11월 1일
추가 정보
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. .