To explore the safety, efficacy and pharmacokinetic (PK) characteristics of triweekly cetuximab in combination with capecitabine as first-line maintenance treatment for KRAS/BRAF wild-type metastatic colorectal cancer: a single-arm, a single-center, Phase 1b trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of triweekly cetuximab combined with a fixed dose of capecitabine using '3+3' dose climbing Phase I experiment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Cetuximab will be given triweekly at a dose from 400mg/m2 to 700mg/m2.
Capecitabine will be given 2 weeks on/1 week off (1000mg/m2 BID po.)
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Safety variables (Incidence of Adverse Events [Safety and Tolerability])
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: 2 year
Pharmacokinetic (PK) characteristics 1
Evaluation Peak Concentration (Cmax) of cetuximab before and after Treatment.
Time frame: 2 year
Pharmacokinetic (PK) characteristics 2
Evaluation Area Under the Curve (AUC0-t, AUC0-∞) of cetuximab before and after Treatment.
Time frame: 2 year
Progression-free survival (PFS)
The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.
Time frame: 2 year
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: 2 year
Objective response rate (ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Time frame: 2 year
Disease Control Rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
Time frame: 2 year
Quality of Life (QOL)
Evaluation of alterations in patients' quality of life throughout treatment by using the EORTC QLQ-CR29 and EORTC QLQ-CR30 quality of life questionnaire. Evaluation of the scores was based on the Karnofsky Performance Scale (KPS). The reliability and validity of the questionnaires were assessed by Cronbach's α coefficient, the Spearman correlation test and Wilcoxon rank sum test.
Time frame: 2 year
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