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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001960
Receipt No. R000002391
Scientific Title Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
Date of disclosure of the study information 2009/06/01
Last modified on 2015/08/01

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Basic information
Public title Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
Acronym Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
Scientific Title Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
Scientific Title:Acronym Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Anticancer efficacy
Key secondary outcomes Duration of effect, Progression free survival, overall survival (Median survival time, 1-year survival rate), Adverse events.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenzo Soejima
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine
Zip code
Address 35 Shinomachi-Shinjyuku
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine
Zip code
Address 35 Shinomachi-Shinjyuku
TEL
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine Division of Pulmonary Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine Division of Pulmonary Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jjco.oxfordjournals.org/content/45/4/356.long
Number of participants that the trial has enrolled
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 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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2015 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
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.

Management information
Registered date
2009 Year 05 Month 12 Day
Last modified on
2015 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002391

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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