A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
2013年1月18日 更新者：Pfizer
A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Cancer
This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.
調査の概要
詳細な説明
The study prematurely discontinued on January 26, 2011 due to slow enrollment.
It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
研究の種類
介入
入学 (実際)
9
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
-
-
District of Columbia
-
Washington、District of Columbia、アメリカ、20007-2197
- Pfizer Investigational Site
-
Washington、District of Columbia、アメリカ、20007
- Pfizer Investigational Site
-
-
Louisiana
-
Marrero、Louisiana、アメリカ、70072
- Pfizer Investigational Site
-
Metairie、Louisiana、アメリカ、70006
- Pfizer Investigational Site
-
-
Missouri
-
Creve Coeur、Missouri、アメリカ、63141
- Pfizer Investigational Site
-
St. Louis、Missouri、アメリカ、63110
- Pfizer Investigational Site
-
St. Louis、Missouri、アメリカ、63110-1094
- Pfizer Investigational Site
-
St. Peters、Missouri、アメリカ、63376
- Pfizer Investigational Site
-
-
New Jersey
-
Morristown、New Jersey、アメリカ、07962
- Pfizer Investigational Site
-
-
North Carolina
-
Hickory、North Carolina、アメリカ、28602
- Pfizer Investigational Site
-
Kernersville、North Carolina、アメリカ、27284
- Pfizer Investigational Site
-
Lenoir、North Carolina、アメリカ、28645
- Pfizer Investigational Site
-
Lexington、North Carolina、アメリカ、27295
- Pfizer Investigational Site
-
Mount Airy、North Carolina、アメリカ、27030
- Pfizer Investigational Site
-
North Wilkesboro、North Carolina、アメリカ、28659
- Pfizer Investigational Site
-
Winston-Salem、North Carolina、アメリカ、27103
- Pfizer Investigational Site
-
-
Oregon
-
Beaverton、Oregon、アメリカ、97006
- Pfizer Investigational Site
-
Gresham、Oregon、アメリカ、97030
- Pfizer Investigational Site
-
Portland、Oregon、アメリカ、97210
- Pfizer Investigational Site
-
Portland、Oregon、アメリカ、97239
- Pfizer Investigational Site
-
Tualatin、Oregon、アメリカ、97062
- Pfizer Investigational Site
-
-
Pennsylvania
-
West Reading、Pennsylvania、アメリカ、19611
- Pfizer Investigational Site
-
-
Virginia
-
Christiansburg、Virginia、アメリカ、24074
- Pfizer Investigational Site
-
Low Moor、Virginia、アメリカ、24457
- Pfizer Investigational Site
-
Roanoke、Virginia、アメリカ、24014
- Pfizer Investigational Site
-
Salem、Virginia、アメリカ、24153
- Pfizer Investigational Site
-
Wytheville、Virginia、アメリカ、24382
- Pfizer Investigational Site
-
-
Washington
-
Everett、Washington、アメリカ、98201
- Pfizer Investigational Site
-
Federal Way、Washington、アメリカ、98003
- Pfizer Investigational Site
-
Gig Harbor、Washington、アメリカ、98332
- Pfizer Investigational Site
-
Kennewick、Washington、アメリカ、99336
- Pfizer Investigational Site
-
Lakewood、Washington、アメリカ、98499
- Pfizer Investigational Site
-
Puyallup、Washington、アメリカ、98372
- Pfizer Investigational Site
-
Tacoma、Washington、アメリカ、98405
- Pfizer Investigational Site
-
-
-
-
Ontario
-
Oshawa、Ontario、カナダ、L1G 2B9
- Pfizer Investigational Site
-
Sudbury、Ontario、カナダ、P3E 5J1
- Pfizer Investigational Site
-
-
Quebec
-
Levis、Quebec、カナダ、G6V 3Z1
- Pfizer Investigational Site
-
Montreal、Quebec、カナダ、H4J 1C5
- Pfizer Investigational Site
-
-
-
-
-
Barcelona、スペイン、08036
- Pfizer Investigational Site
-
Barcelona、スペイン、08025
- Pfizer Investigational Site
-
Las Palmas de Gran Canaria、スペイン、35016
- Pfizer Investigational Site
-
Madrid、スペイン、28041
- Pfizer Investigational Site
-
Malaga、スペイン、29010
- Pfizer Investigational Site
-
Sevilla、スペイン、41013
- Pfizer Investigational Site
-
Sevilla、スペイン、41009
- Pfizer Investigational Site
-
Valencia、スペイン、46026
- Pfizer Investigational Site
-
-
-
-
-
Budapest、ハンガリー、1125
- Pfizer Investigational Site
-
Debrecen、ハンガリー、4032
- Pfizer Investigational Site
-
Deszk、ハンガリー、6772
- Pfizer Investigational Site
-
Farkasgyepu、ハンガリー、8582
- Pfizer Investigational Site
-
Torokbalint、ハンガリー、2045
- Pfizer Investigational Site
-
-
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:
- Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or = 120 ng/ml
Exclusion Criteria:
- Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
- HbA1c > or = 5.7%
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Arm A
Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
|
Figitumumab (20 mg/kg)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
|
|
アクティブコンパレータ：Arm B
Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
|
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
|
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 |
|---|---|---|
|
Progression-Free Survival (PFS)
時間枠：Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
|
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].
|
Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Objective Response
時間枠：Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
|
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Confirmed CR defined as disappearance of all target lesions.
Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.
|
Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
|
|
Overall Survival (OS)
時間枠：Every 3 months until death or 12 months from the date the last participant was randomized
|
Overall survival was the duration from enrollment to death due to any cause.
For participants who are alive, overall survival was censored at the last contact.
Survival time (days) = [death date (last known alive date) - date of randomization +1].
|
Every 3 months until death or 12 months from the date the last participant was randomized
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline up to follow-up (90 days post dose)
|
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment.
The event does not need to be causally related to the study treatment.
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.
|
Baseline up to follow-up (90 days post dose)
|
|
Maximum Observed Plasma Concentration (Cmax) of Figitumumab
時間枠：Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
|
Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
|
|
|
Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab
時間枠：Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
|
Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
|
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide
時間枠：Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
|
Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
|
|
Maximum Observed Plasma Concentration (Cmax) of Etoposide
時間枠：Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
|
Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
|
|
|
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
時間枠：Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
|
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
|
Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
|
|
Cancer Dyspnea Scale (CDS) Score
時間枠：Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
|
The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer.
The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 "Not at All" to 5 "Very Much").
|
Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
|
|
Numeric Rating Scale (NRS) Score
時間枠：Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
|
The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess "worst pain" severity.
Overall scores range from 0 to 10, with low scores representing a lower level of pain.
|
Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
|
|
Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
時間枠：Baseline prior to dosing
|
Baseline prior to dosing
|
|
|
Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers
時間枠：Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
|
Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
|
|
|
Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs
時間枠：Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)
|
Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs
|
Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab 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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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4月1日
一次修了 (実際)
2011年10月1日
研究の完了 (実際)
2011年10月1日
試験登録日
最初に提出
2009年9月10日
QC基準を満たした最初の提出物
2009年9月14日
最初の投稿 (見積もり)
2009年9月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年2月25日
QC基準を満たした最後の更新が送信されました
2013年1月18日
最終確認日
2013年1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。