UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001730 |
|---|---|
| Receipt number | R000002068 |
| Scientific Title | Pilot study of gefitinib and irinotecan in young patients With Relapsed or Refractory Cancer |
| Date of disclosure of the study information | 2009/02/23 |
| Last modified on | 2011/05/23 17:53:03 |
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Basic information
Public title
Pilot study of gefitinib and irinotecan in young patients With Relapsed or Refractory Cancer
Acronym
Ir2 for Relapsed Pediatric and AYA cancer pilot trial
Scientific Title
Pilot study of gefitinib and irinotecan in young patients With Relapsed or Refractory Cancer
Scientific Title:Acronym
Ir2 for Relapsed Pediatric and AYA cancer pilot trial
Region
| Japan |
Condition
Condition
Relapse/ refractory pediatric and adolescent and young adult cancer
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. To assess dose limiting toxicity of gefitinib and irinotecan combination regimen in from children to young adult
2. To characterize the pharmacokinetics of irinotecan and gefitinib in their concurrent administration in young population
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
incidence of dose limiting toxicity
Key secondary outcomes
incidence of adverse event, pharmacokinetic parameter,
feasibility of concurrent administration of gefitinib and irinotecan
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
gefitinib and irinotecan regimen in which gefitinib 112.5mg/m2/day p.o. on days 1-12, irinotecan 30mg/m2 DIV over 30 min on days 1-5, and cefixime 8mg/kg/day p.o. on days -1-14 on to be repeated every 3 weeks until progression
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
| 1 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. neuroblastoma, retinoblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, osteosarcoma, glioma, meduloblastoma, germ cell tumor
2. relapse or progression following disease specific first-line standard chemotherapies
3. no prior use of irinotecan, gefitinib, erlotinib, or cetuximab
4. evidence of progression in clinical signs or symptoms or on imaging studies
5. > 14 days since prior antitumor cytotoxic agents except nitrosourea and > 28 days since prior nitrosourea
6. >= 14 days for local palliative radiation and > 6 months must have
elapsed if prior craniospinal XRT or if >= 50% radiation of pelvis and >= 8 weeks must have elapsed if conventional radiation for brain tumor and >= 6 weeks
must have elapsed if other substantial BM radiation
7. > 14 days since prior surgery (containing open biopsy)
8. 0-2 in ECOG PS
9. no findings of interstitial pneumonia on CT
11. no signs or symptoms equivalent to CTC-AE Grade2 diarrhea
12. confirming the following laboratory results within 14 days
(1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration)
(2) Platelet count >= 75,000/mm~3 (platelet transfusions allowed)
(3) serum total Bilirubin <= 1.2mg/dl
(4) ALT <= 100 IU/l
(5) Creatinine adjusted according to age as follows:
<= 0.6 mg/dl (1 year-23 months)
<= 0.8 mg/dl (2 years-5 years)
<= 0.9 mg/dl (6 years-9 years)
<= 1.1 mg/dl (10 years-12 years [male])
<= 1.0 mg/dl (10 years-12 years [female])
<= 1.5 mg/dl (13 years-15 years [male])
<= 1.2 mg/dl (13 years and over [female])
<= 1.7 mg/dl (16 years and over [male])
13. legal adult: Written informed consent
14. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian
15. 15 years and under: written informed consent from legal guardian
Key exclusion criteria
1. >4 weeks since prior CYP3A4 inducer uptake
2. >1 week since prior CYP3A4 inhibitor uptake
3. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment
4. Active infection requiring systemic medication
5. abnormality in electrocardiogram tested within 28 days, requiring intervention
6. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion
7. Women during pregnancy or breast-feeding
8. Psychosis
9. Systemic steroids or immunosuppressants medication except for continuous steroid use for increased intracranial pressure and/or brain edema
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawamoto |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
pediatric division/ clinical reserch division
Zip code
Address
18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
03-3823-2101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawamoto |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
pediatric division/ clinical reserch division
Zip code
Address
18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
03-3823-2101
Homepage URL
http://www.nposuccess.jp/datacenter/index.html
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
pediatric division/musculoskeltal oncology division/ neurology division
Institute
Department
Personal name
Funding Source
Organization
Group for for "Investigation of feasibility evaluation for clinical application of off-label drugs based on systematic series of clinical trials in pediatric solid malignancy"
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NPO SUCCESS Support Center for Therapeutic Development
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://abstract.asco.org/AbstView_102_80999.html
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
Terminated
Date of protocol fixation
| 2009 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 23 | Day |
Last modified on
| 2011 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002068
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
