UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000965 |
|---|---|
| Receipt number | R000001162 |
| Scientific Title | Phase 2 study of cisplatin and pemetrexed in previously treated patients with malignant pleural mesothelioma |
| Date of disclosure of the study information | 2008/01/04 |
| Last modified on | 2011/01/04 17:19:59 |
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Basic information
Public title
Phase 2 study of cisplatin and pemetrexed in previously treated patients with malignant pleural mesothelioma
Acronym
Phase 2 study of cisplatin and pemetrexed in previously treated patients with malignant pleural mesothelioma
Scientific Title
Phase 2 study of cisplatin and pemetrexed in previously treated patients with malignant pleural mesothelioma
Scientific Title:Acronym
Phase 2 study of cisplatin and pemetrexed in previously treated patients with malignant pleural mesothelioma
Region
| Japan |
Condition
Condition
Malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of pemetrexed plus cisplatin therapy as second-line treatment in malignant pleural mesothelioma patients with previously treated with chemotherapy drugs except for pemetrexed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response Rate
Overall survival
Incidence of treatment-emergent 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
21-Day period as one course.Cisplatin 60mg/m2 and pemetrexed 500mg/m2 on Day1.Repeat for 2-6 courses
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
Male and Female
Key inclusion criteria
1. Pathologically proved malignant pleural mesothelioma
2. Patients who were not candidates for curative surgery.
3. Previously treated with chemotherapy drugs except for pemetrexed.
4. Measurable disease
5. Age : >=20 and <75
6. Performance status of 0-1 (ECOG)
7. Treatment area of irradiation <= 25% of hematogenous marrow
8. More than 21days after surgery
9. Adequate organ function listed below.
Hb: >=9.0g/dL
WBC: >=3,000/mm3 or Neu: >=2,000/mm3
Plt: >=100,000/mm3
AST and ALT: <=2.5times the upper limit of normal
T-Bil: <= 1.5times the upper limit of normal
Cr: <1.5mg/dL
SpO2 (or SaO2): >=92%
ECG: normal
10. Patients with an estimated life expectancy of more than 12 weeks
11. Written informed consent
Key exclusion criteria
1. Serious or uncontrolled complication
2. Active infection
3. Active concomitant malignancy
4. Symptomatic brain metastasis
5. With prior unapproved drugs or investigational new drugs
6. With a history of sensitivity to platinum agent, folic acid or vitamin B12
7. Women with confirmed, lactating or suspected pregnancy. Patients who won't avoid pregnancy.
8. Peripheral neuropathy >= grade 2
9. Interstitial pneumonia or fibroid lung
10. Medically endorsed anticonception can't be assured till 90 days after the final administration
11. Inappropriate patients for entry on this trial in the judgment of the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Hyogo College of Medicine
Division name
Division of Respiratory Medicine, Dept. of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho Nishinomiya City Hyogo
TEL
0798-45-6596
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Japan Mesothelioma Research Center (JMRC)
Division name
Japan Mesothelioma Research Center (JMRC)
Zip code
Address
TEL
0798-45-6088
Homepage URL
http://www.hyo-med.ac.jp/department/jmrc/index.html
choseihi@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2007 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 04 | Day |
Last modified on
| 2011 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001162
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