UMIN試験ID | UMIN000001960 |
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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 09:49:19 |
日本語
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
英語
Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
日本語
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
英語
Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
日本語
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
英語
Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
日本語
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
英語
Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
日本/Japan |
日本語
非小細胞肺癌
英語
Non-small cell lung cancer
呼吸器内科学/Pneumology |
悪性腫瘍/Malignancy
いいえ/NO
日本語
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。
英語
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.
安全性・有効性/Safety,Efficacy
日本語
英語
検証的/Confirmatory
実務的/Pragmatic
第Ⅰ・Ⅱ相/Phase I,II
日本語
抗腫瘍効果
英語
Anticancer efficacy
日本語
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
英語
Duration of effect, Progression free survival, overall survival (Median survival time, 1-year survival rate), Adverse events.
介入/Interventional
単群/Single arm
非ランダム化/Non-randomized
オープン/Open -no one is blinded
無対照/Uncontrolled
1
治療・ケア/Treatment
医薬品/Medicine |
日本語
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。
英語
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.
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
20 | 歳/years-old | 以上/<= |
75 | 歳/years-old | 以下/>= |
女/Female
日本語
(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
英語
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
日本語
(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
英語
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
36
日本語
名 | |
ミドルネーム | |
姓 | 副島 研造 |
英語
名 | |
ミドルネーム | |
姓 | Kenzo Soejima |
日本語
慶應義塾大学医学部
英語
Keio University School of Medicine
日本語
呼吸器内科
英語
Division of Pulmonary Medicine
日本語
新宿区信濃町35
英語
35 Shinomachi-Shinjyuku
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | |
ミドルネーム | |
姓 |
日本語
慶應義塾大学医学部
英語
Keio University School of Medicine
日本語
呼吸器内科
英語
Division of Pulmonary Medicine
日本語
新宿区信濃町35
英語
35 Shinomachi-Shinjyuku
日本語
その他
英語
Keio University School of Medicine Division of Pulmonary Medicine
日本語
慶應義塾大学医学部呼吸器内科
日本語
日本語
英語
日本語
その他
英語
Keio University School of Medicine Division of Pulmonary Medicine
日本語
慶應義塾大学医学部呼吸器内科
日本語
自己調達/Self funding
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
いいえ/NO
日本語
英語
日本語
英語
2009 | 年 | 06 | 月 | 01 | 日 |
最終結果が公表されている/Published
http://jjco.oxfordjournals.org/content/45/4/356.long
日本語
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.
英語
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.
日本語
英語
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試験終了/Completed
2006 | 年 | 03 | 月 | 02 | 日 |
2006 | 年 | 10 | 月 | 01 | 日 |
2015 | 年 | 02 | 月 | 01 | 日 |
日本語
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.
英語
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.
2009 | 年 | 05 | 月 | 12 | 日 |
2015 | 年 | 08 | 月 | 01 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000002391
英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002391
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