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利用者名:
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試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000001960
受付番号 R000002391
科学的試験名 既治療非小細胞肺癌に対するCPT-11+S-1併用療法の第Ⅰ/Ⅱ相試験
一般公開日(本登録希望日) 2009/06/01
最終更新日 2015/08/01

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 既治療非小細胞肺癌に対するCPT-11+S-1併用療法の第Ⅰ/Ⅱ相試験 Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
一般向け試験名略称/Acronym 既治療非小細胞肺癌に対するCPT-11+S-1併用療法の第Ⅰ/Ⅱ相試験 Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
科学的試験名/Scientific Title 既治療非小細胞肺癌に対するCPT-11+S-1併用療法の第Ⅰ/Ⅱ相試験 Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
科学的試験名略称/Scientific Title:Acronym 既治療非小細胞肺癌に対するCPT-11+S-1併用療法の第Ⅰ/Ⅱ相試験 Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 非小細胞肺癌 Non-small cell lung cancer
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 前化学療法無効または抵抗性の非小細胞肺癌を対象に、CPT-11+S-1併用療法における最大耐用量(MTD)を明らかにし、推奨投与量(RD)を決定するとともに推奨用量での安全性と有効性を検討する。 To verify the maximumm tolerated dose (MTD) and recommended dose (RD) of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer. To investigate safety and efficacy of recomended dose CPT-11 + S-1 combination therapy.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅰ・Ⅱ相/Phase I,II

評価/Assessment
主要アウトカム評価項目/Primary outcomes 抗腫瘍効果 Anticancer efficacy
副次アウトカム評価項目/Key secondary outcomes 効果持続期間、無増悪生存期間、生存期間(Median survival time、1年生存率)、有害事象 Duration of effect, Progression free survival, overall survival (Median survival time, 1-year survival rate), Adverse events.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 単群/Single arm
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無対照/Uncontrolled
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 1
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1 CPT-11 は day 1、day 8 に静脈内投与。S-1 は day 1 から day 14 まで連日経口投与。 CPT-11 is administered intravenously on day 1 and day 8 every 21 days. S-1 is administered given orally from day 1 to day 14 every 21 days.
介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
75 歳/years-old 以下/>=
性別/Gender 女/Female
選択基準/Key inclusion criteria (1)組織診あるいは細胞診により非小細胞肺癌と診断されている症例
(2)RECISTでの測定可能病変を有する症例
(3)前化学療法(分子標的薬を除く)を有する症例 (second-line)
(4)一般状態 ECOG Performance Status (P.S.) が 0~1 の症例
(5)主要臓器機能(骨髄、肝、腎および心肺機能)が保持されている症例
WBC ≧ 4,000 /mm3かつ≦ 12,000 /mm3
Neu ≧ 2,000 /mm3
Plt ≧ 100,000 /mm3
Hb ≧ 9.5 g/dL
AST、ALT ≦ 100IU/L
T-Bil ≦ 1.5 ㎎/dL
血清クレアチニン ≦ 1.2 ㎎/dL
PaO2 ≧ 70 Torr(ただし、原病よる低酸素血症の場合には、PaO2 ≧ 60 Torr)
(6)同意取得時の年齢が20歳以上75歳以下の症例
(7)3ヶ月以上の生存が期待される症例
(8)本試験の参加について、被験者本人より文書で同意が得られている症例
1) Patients with histlogically or cytologically confirmed non-small cell lung cancer
2) Patients with mesearable lesions as defined by RECIST
3) Patients with the prior one chemotherapy except molecular-targeted drug
4) Performance Status(ECOG) 0-2
5) Patients with adequate organ functions
WBC >= 4000/mm3 and <= 12,000/mm3
neutrophil count >= 2000/mm3
Platelet count >= 100,000/mm3
Hemoglobin >= 9.0g/dl
AST, ALT <= 100IU/L
Total bilirubin <= 1.5 mg/dl
Serum creatinine <= 1.5 mg/dl
PaO2 >= 70 torr (if the reason of hypoxemia is the primary disease, PaO2 >= 60 torr)
6) >= 70 years of age
7) Life expectancy more than three months
8) Written informed consent
除外基準/Key exclusion criteria (1)感染症を合併している症例(感染症の合併を疑われる症例)
(2)ドレナージを必要とする大量の胸水、腹水、心嚢液を有する症例
(3)明らかな肺腺維症あるいは間質性肺炎を有する症例
(4)下痢(水様便)を呈する症例
(5)腸管麻痺、腸閉塞を有する症例
(6)臨床上問題となる心疾患を有する症例
(7)その他重篤な合併症を有する症例
(8)妊婦、授乳婦および妊娠の可能性ある女性
(9)活動性の重複がんを有する症例
(10)症状を有する脳転移症例
(11)フルシトシンを投与中の症例
(12)硫酸アタザナビルを投与中の症例
1) Patients with infections
2) Patients with massive pleural or pericardial effusion ,or ascites
3) Patients with pulmonary fibrosis interstitial pneumonia
4) Patients with diarrhea
5) Patients with intestinal paralysis or intestinal obstruction
6) Patients clinically important heart disease
7) Patients with significant complications
8) Patients with pregnancy or lactation
9) Patients with active concomitant malignancy
10) Patients with symptomatic brain metastasis
11) Patients in the administration of flucytosine
(12) Patients in the administration of atazanavir sulfate
目標参加者数/Target sample size 36

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム
副島 研造

ミドルネーム
Kenzo Soejima
所属組織/Organization 慶應義塾大学医学部 Keio University School of Medicine
所属部署/Division name 呼吸器内科 Division of Pulmonary Medicine
郵便番号/Zip code
住所/Address 新宿区信濃町35 35 Shinomachi-Shinjyuku
電話/TEL
Email/Email

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム

組織名/Organization 慶應義塾大学医学部 Keio University School of Medicine
部署名/Division name 呼吸器内科 Division of Pulmonary Medicine
郵便番号/Zip code
住所/Address 新宿区信濃町35 35 Shinomachi-Shinjyuku
電話/TEL
試験のホームページURL/Homepage URL
Email/Email

実施責任組織/Sponsor
機関名/Institute その他 Keio University School of Medicine Division of Pulmonary Medicine
機関名/Institute
(機関選択不可の場合)
慶應義塾大学医学部呼吸器内科
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Keio University School of Medicine Division of Pulmonary Medicine
機関名/Organization
(機関選択不可の場合)
慶應義塾大学医学部呼吸器内科
組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2009 06 01

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications http://jjco.oxfordjournals.org/content/45/4/356.long
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results Background
This phase I study was conducted to evaluate the feasibility and to determine the recommended doses of the combination therapy of S-1 and irinotecan (CPT-11) in patients with advanced non-small cell lung cancer (NSCLC) as second-line treatment.

Methods
Patients with NSCLC who were previously treated with one chemotherapy regimen and had a performance status of 0 or 1 were eligible. CPT-11 was administered at 60 mg/m2 (level 1), 80 mg/m2 (level 2) on days 1 and 8, and oral S-1 was administered at 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA 1.25-1.5 m2, and 120 mg/day for BSA more than 1.5 m2 on days 1-14 every 3 weeks. The dose-limiting toxicity (DLT) was defined as grade 4 leukocytopenia or neutropenia, grade >=3 neutropenia with fever over 38°C, grade >=3 thrombocytopenia, or grade >=3 major nonhematological toxicities.

Results
Nine patients were enrolled in the study. None of 3 patients enrolled in level 1 had any DLT. Of 6 patients in level 2, 2 patients had grade 3 diarrhea and one had grade 3 interstitial pneumonia. Level 1 was declared as the recommended dose.

Conclusion
The feasibility of the combination therapy of S-1 and CPT-11 was shown in the second-line setting for the treatment of advanced NSCLC. The recommended dose of CPT-11 was 60 mg/m2 combined with standard dose of S-1 for phase II trials of pretreated advanced NSCLC patients.
Background
This phase I study was conducted to evaluate the feasibility and to determine the recommended doses of the combination therapy of S-1 and irinotecan (CPT-11) in patients with advanced non-small cell lung cancer (NSCLC) as second-line treatment.

Methods
Patients with NSCLC who were previously treated with one chemotherapy regimen and had a performance status of 0 or 1 were eligible. CPT-11 was administered at 60 mg/m2 (level 1), 80 mg/m2 (level 2) on days 1 and 8, and oral S-1 was administered at 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA 1.25-1.5 m2, and 120 mg/day for BSA more than 1.5 m2 on days 1-14 every 3 weeks.
The dose-limiting toxicity (DLT) was defined as grade 4 leukocytopenia or neutropenia, grade >=3 neutropenia with fever over 38degree, grade >=3 thrombocytopenia, or grade >=3 major nonhematological toxicities.

Results
Nine patients were enrolled in the study. None of 3 patients enrolled in level 1 had any DLT. Of 6 patients in level 2, 2 patients had grade 3 diarrhea and one had grade 3 interstitial pneumonia. Level 1 was declared as the recommended dose.



Conclusion
The feasibility of the combination therapy of S-1 and CPT-11 was shown in the second-line setting for the treatment of advanced NSCLC. The recommended dose of CPT-11 was 60 mg/m2 combined with standard dose of S-1 for phase II trials of pretreated advanced NSCLC patients.
主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2006 03 02
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2006 10 01
フォロー終了(予定)日/Last follow-up date
2015 02 01
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information Objective This Phase II study was conducted to evaluate the efficacy and safety of S-1 and irinotecan combination therapy as a second-line treatment in patients with advanced non-small cell lung cancer.

Methods Irinotecan was administered at 60 mg/m2 on Days 1 and 8. Oral S-1 was administered on Days 1-14 every 3 weeks at 80 mg/day for patients with a body surface area of <1.25 m2, 100 mg/day for patients with a body surface area of 1.25-1.5 m2 and 120 mg/day for patients with a body surface area of >1.5 m2. The primary endpoint was response rate, while the secondary endpoints were progression-free survival, overall survival and safety.

Results Thirty-one patients were enrolled in this study. The response and disease control rates were 6.5 and 58.1%, respectively. Progression-free survival and median survival time were 2.8 and 12.6 months, respectively. Grade 3-4 adverse events were reported for 29.0% of the patients. Hematological toxicities of Grade 3 or 4 included leukopenia (9.7%), neutropenia (9.7%), febrile neutropenia (3.2%), thrombopenia (3.2%) and anemia (6.5%). Non-hematological toxicities of Grade 3 or 4 included pneumonitis (6.5%), diarrhea, colitis, dyspnea, rash, oral mucositis, anorexia and pulmonary thromboembolism/deep vein thrombosis (3.2% each).

Conclusions S-1 and irinotecan combination therapy at the present dose and schedule exhibited only modest efficacy with mild toxicities in previously treated patients with non-small cell lung cancer. No further clinical investigation with current dose and schedules is warranted for patients with non-small cell lung cancer who failed first-line platinum-based doublet chemotherapy.
Objective This Phase II study was conducted to evaluate the efficacy and safety of S-1 and irinotecan combination therapy as a second-line treatment in patients with advanced non-small cell lung cancer.

Methods Irinotecan was administered at 60 mg/m2 on Days 1 and 8. Oral S-1 was administered on Days 1-14 every 3 weeks at 80 mg/day for patients with a body surface area of <1.25 m2, 100 mg/day for patients with a body surface area of 1.25-1.5 m2 and 120 mg/day for patients with a body surface area of >1.5 m2. The primary endpoint was response rate, while the secondary endpoints were progression-free survival, overall survival and safety.

Results Thirty-one patients were enrolled in this study. The response and disease control rates were 6.5 and 58.1%, respectively. Progression-free survival and median survival time were 2.8 and 12.6 months, respectively. Grade 3-4 adverse events were reported for 29.0% of the patients. Hematological toxicities of Grade 3 or 4 included leukopenia (9.7%), neutropenia (9.7%), febrile neutropenia (3.2%), thrombopenia (3.2%) and anemia (6.5%). Non-hematological toxicities of Grade 3 or 4 included pneumonitis (6.5%), diarrhea, colitis, dyspnea, rash, oral mucositis, anorexia and pulmonary thromboembolism/deep vein thrombosis (3.2% each).

Conclusions S-1 and irinotecan combination therapy at the present dose and schedule exhibited only modest efficacy with mild toxicities in previously treated patients with non-small cell lung cancer. No further clinical investigation with current dose and schedules is warranted for patients with non-small cell lung cancer who failed first-line platinum-based doublet chemotherapy.

管理情報/Management information
登録日時/Registered date
2009 05 12
最終更新日/Last modified on
2015 08 01


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000002391
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002391

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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