Trial Information
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors
Inclusion Criteria:
- Small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer
and gastric cancer
- Patients with UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
- Patients to receiving CPT-11 plus platinum analogues (cisplatin, carboplatin and
nedaplatin) regimens (with or without molecular targeted agents)
Exclusion Criteria:
- Contraindication of CPT-11
- ECOG PS 3-4
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Influence of UGT1A1 genotypes on severe toxicities (ex. neutropenia) induced by CPT-11 based regimens
Outcome Time Frame:
3 or 6 months
Safety Issue:
Yes
Principal Investigator
Masashi Takano, MD. PhD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Obstetrics and Gynecology, National Defense Medical College
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
TOP009-062
NCT ID:
NCT01040312
Start Date:
October 2009
Completion Date:
March 2014
Related Keywords:
- Small Cell Lung Cancer
- Non-Small Cell Lung Cancer
- Cervical Cancer
- Ovarian Cancer
- Gastric Cancer (Inoperable and Recurrent)
- UGT1A1, irinotecan
- Carcinoma, Non-Small-Cell Lung
- Uterine Cervical Neoplasms
- Lung Neoplasms
- Stomach Neoplasms
- Ovarian Neoplasms
- Small Cell Lung Carcinoma