Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies
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|ClinicalTrials.gov Identifier: NCT01705106|
Recruitment Status : Terminated (The study was terminated early due to slow accrual.)
First Posted : October 12, 2012
Results First Posted : May 30, 2018
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: capecitabine Drug: celecoxib Other: pharmacological study Other: laboratory biomarker analysis Other: pharmacogenomic studies||Phase 1|
I. To compare steady state pharmacokinetics (PK) (primarily minimum concentration [Cmin], maximum concentration [Cmax], and area under the curve [AUC]) of celecoxib on day 7 of monotherapy versus on day 14 of concomitant administration with capecitabine.
I. To develop a celecoxib PK drug interaction model using longitudinal data and determine whether the results are concordant with results from the primary objective.
II. To assess the impact of known cytochrome P450 2C9 (CYP2C9) pharmacogenetic variants with reduced enzyme activity (CYP2C9*2 and *3) on the between subject variability in celecoxib PK.
III. To assess tumor response by the Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) and explore whether there is any correlation between celecoxib PK and response.
IV. To assess toxicity by the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) and explore whether there is any correlation between celecoxib PK and toxicities related to either celecoxib or capecitabine.
Patients receive celecoxib orally (PO) twice daily (BID) for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Drug-drug Interaction Study of Capecitabine and Celecoxib in Patients With Advanced Solid Malignancies|
|Actual Study Start Date :||August 29, 2012|
|Actual Primary Completion Date :||February 10, 2016|
|Actual Study Completion Date :||February 10, 2016|
Experimental: Treatment (capecitabine, celecoxib)
Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Other Name: Pharmacogenomic Study
- AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7) [ Time Frame: Day 7 and 14 post treatment ]These parameters will be estimated for each subject under each treatment condition. The mean ratios (combination therapy/celecoxib monotherapy) will then be estimated together with 90% confidence intervals (CI).
- CYP2C9 Genotype [ Time Frame: one week ]Polymorphisms *2 and *3 will be genotyped and analyzed for their impact on celecoxib AUC using analysis of variance (ANOVA), controlling for gender, age, and other covariates.
- Response Rate [ Time Frame: Up to 2 years ]Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.
- Drug-related Toxicities [ Time Frame: Up to six months ]Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.
- PK Drug Interaction Model [ Time Frame: 4 weeks ]NONMEM software will be used to develop a model describing the drug interaction between capecitabine and celecoxib using PK data collected during the first four weeks of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705106
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Manish R. Sharma, M.D.||University of Chicago Comprehensive Cancer Center|