Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
2015年11月24日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
72
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Casa Grande、Arizona、アメリカ、85122
- Donald W. Hill M.D., P.C.
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California
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Beverly Hills、California、アメリカ、90211
- Beverly Hills Cancer Center
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Los Angeles、California、アメリカ、90036
- Cancer Care Institute
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Oakland、California、アメリカ、94609
- Northern California Hematology & Oncology
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San Diego、California、アメリカ、92123
- Sharp Clinical Oncology Research
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Florida
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Ft. Lauderdale、Florida、アメリカ、33308
- Broward Oncology Associates, P.A.
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Miami、Florida、アメリカ、33125
- Elite Research Institute
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Illinois
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Skokie、Illinois、アメリカ、60076
- Edward H. Kaplan, MD & Associates
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Minnesota
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Edina、Minnesota、アメリカ、55435
- Fairview Southdale Medical Oncology Clinic
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North Dakota
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Bismarck、North Dakota、アメリカ、58501
- Mid Dakota Clinic, PC
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19140
- Temple University Hospital
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Texas
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Lubbock、Texas、アメリカ、79415
- University Medical Center
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Washington
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Kennewick、Washington、アメリカ、99336
- Columbia Basin Hematology and Oncology
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New Brunswick
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Moncton、New Brunswick、カナダ、E1C 6Z8
- The Moncton Hospital
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Newfoundland and Labrador
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Grand Falls-Windsor、Newfoundland and Labrador、カナダ、A2A 2E2
- Local Institution
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Ontario
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Mississauga、Ontario、カナダ、L5M 2N1
- The Credit Valley Hospital
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Sudbury、Ontario、カナダ、P3E 5J1
- Sudbury Regional Hospital
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Thunder Bay、Ontario、カナダ、P7B 6V4
- Thunder Bay Regional Health Sciences Centre (Regional Cancer Care)
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Toronto、Ontario、カナダ、M4C 3E7
- Toronto East General Hospital
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Quebec
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Rimouski、Quebec、カナダ、G5L 5T1
- Centre De Sante Et De Services Sociaux De Rimouski-Neigette
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Ponce、プエルトリコ、00716
- Ponce School of Medicine (Caimed Center)
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San Juan、プエルトリコ、00927
- Fundacion de Investigacion de Diego
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Cetuximab + Cisplatin + Vinorelbine
|
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
他の名前：
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
他の名前：
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
時間枠：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
時間枠：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.
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Day 1 up to 30 days after last dose
|
|
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
時間枠：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.
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Day 2 up to 30 days after last dose
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Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
時間枠：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.
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Day 1 up to 30 days after last dose
|
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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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年7月1日
一次修了 (実際)
2012年9月1日
研究の完了 (実際)
2012年9月1日
試験登録日
最初に提出
2010年4月22日
QC基準を満たした最初の提出物
2010年4月22日
最初の投稿 (見積もり)
2010年4月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年12月24日
QC基準を満たした最後の更新が送信されました
2015年11月24日
最終確認日
2015年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。