An observational study in Solid Tumors, Docetaxel and Drug-Related Side Effects and Adverse Reactions, sponsored by Cui Yimin. Status unknown at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Cui Yimin · Observational
Taxanes are one of the most active agents in the treatment of many kinds of solid tumors, mainly including paclitaxel and docetaxel. However, variability in toxicity and response remains a major problem for patients receiving taxanes. It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Toxicities of docetaxel, such as myelosuppression, neurotoxicity or mucositis, were evaluated for possible relationship with pharmacogenetic polymorphisms in several candidate gene and genome-wide association studies. Due to the levels of evidence of those studies are low and lack of sufficient research data of Chinese, it has the important significance in studying individual differences of docetaxel in toxicities, through the pharmacogenomics research.
The aim of this study is to evaluating the association genetic polymorphisms with docetaxel-based chemotherapy toxicities in chinese solid tumor patients. By detecting the gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG) correlation of docetaxel and provide scientific basis for precise medication guide for people to use docetaxel.
Chinese solid tumor patients with the treatment of docetaxel-based chemotherapy.
Have adequate organ function, including:
Bone marrow reserve:
Hepatic:
Exclusion Criteria;
Through next generation sequencing, distinguish wild genotype of docetaxel
Genetic: detection of genotype
Through next generation sequencing, distinguish mutant genotype of docetaxel
Genetic: detection of genotype
detection of genotype by next generation sequencing
Incidence of severe hematological toxicity
The toxicity induced by docetaxel-based chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 4.03. Patients with grade 3-4 adverse events will be considered as having severe toxicity. At the end of each cycle (each cycle is 21 days) the grade will be scored. And the severest grade will be recorded and used for analysis. Hematological toxicity includes neutropenia, leukopenia, anemia and thrombocytopenia.
Time frame: At 1 year
Incidence of other severe toxicities
The other toxicities induced by docetaxel-based chemotherapy during observation time, including gastrointestinal toxicity, neurotoxicity etc., will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 4.03. Toxicities with grade 3-4 will be considered as severe toxicity, except for severe neurotoxicity (grade 2-3). At the end of each cycle (each cycle is 21 days) the grade will be scored. And the severest grade will be recorded and used for analysis.
Time frame: At 1 year
Genotyping
Collect blood specimen, then detect genotype by next generation sequencing.
Time frame: Before chemotherapy
The kinds of the metabolites
Determine the metabolic profiles of docetaxel. This outcome is not applicable to patients retrospectively collected.
Time frame: Pre-dose and 6 hours post-dose in the first cycle
Area under the curve [AUC]
Determine the AUC of docetaxel and its metabolites. This outcome is not applicable to patients retrospectively collected.
Time frame: Pre-dose and 6 hours post-dose in the first cycle
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Drug-Related Side Effects and Adverse Reactions→
Cui Yimin