Pilot study of gefitinib and irinotecan in young patients With Relapsed or Refractory Cancer
- Conditions
- Relapse/ refractory pediatric and adolescent and young adult cancer
- Registration Number
- JPRN-UMIN000001730
- Lead Sponsor
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital pediatric division/musculoskeltal oncology division/ neurology division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of dose limiting toxicity
- Secondary Outcome Measures
Name Time Method incidence of adverse event, pharmacokinetic parameter, feasibility of concurrent administration of gefitinib and irinotecan