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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003231
Receipt No. R000003909
Scientific Title Phase I Study of Pemetrexed Combined with Carboplatin for Elderly Patients with Advanced Non-small Cell Lung Cancer
Date of disclosure of the study information 2010/02/22
Last modified on 2015/02/27

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Basic information
Public title Phase I Study of Pemetrexed Combined with Carboplatin for Elderly Patients with Advanced Non-small Cell Lung Cancer
Acronym Phase I Study of PEM/CBDCA for elderly NSCLC
Scientific Title Phase I Study of Pemetrexed Combined with Carboplatin for Elderly Patients with Advanced Non-small Cell Lung Cancer
Scientific Title:Acronym Phase I Study of PEM/CBDCA for elderly NSCLC
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety, feasibility and to determine the recommended dose of CBDCA+PEM for elderly patients with advanced NSCLC
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes To estimate maximum tolerated dose and determine the recommended dose
Key secondary outcomes

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 Pemetrexed
Carboplatin
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven non-small-cell lung cancer.
2) Aged >= 75 years.
3) ECOG performance status: 0-1
4) Patient who has measurable lesion by RECIST.
5) No prior chemotherapy for NSCLC. Interval from previous treatment, of following, at enrollment;
(a) Surgery: more than 4 weeks after surgery.
(b) Radiation: more than 4 weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs.
6) No history of receiving chemotherapy against other concomitant malignancy.
7) Adequate organ functions;
(a) WBC >= 4,000/mm3 and Netrophile >= 2,000/mm3
(b) Hb >= 9.0 g/dL
(c) Plt >= 100,000/mm3
(d) T. Bil <= 1.5 g/dL
(e) AST and ALT, <= 100 U/L
(f) Serum creatinine <= 1.5 mg/dL and Ccr >= 45ml/min/body
(g) PaO2 >= 70 torr (at room)
8) Written informed consent.
9) Life expectancy >= 3 months
Key exclusion criteria 1) Patients with active concomitant malignancy.
2) Patients with massive pleural or pericardial effusion.
3) Patients with symptomatic brain metastasis.
4) Patients with diarrhea or ileus at enrollment.
5) Active lung disease such as interstitial pneumonia, idiopathic pulmonary fibrosis.
6) Patients with other clinically significant complications.
(a) uncontrollable cardiovascular disease.
(b) uncontrollable diabetes and hypertension.
(c) Active severe infections.
(d) History of active psychological disease.
7) Patients with steroid treatment.
8) Patients who had a history of severe drug allergy.
9) Inappropriate patients for this study judged by the physicians.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Yamada
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942-31-7560
Email kayamada@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Takeoka, Kazuhiko Yamada
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942-31-7560
Homepage URL
Email kayamada@med.kurume-u.ac.jp

Sponsor
Institute Division of Respirology, Neurology, and Rheumatology,
Department of Internal Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization Division of Respirology, Neurology, and Rheumatology,
Department of Internal Medicine, Kurume University School of 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
2010 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2010 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 22 Day
Last modified on
2015 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003909

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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