NCT01705106

Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies

A Drug-drug Interaction Study of Capecitabine and Celecoxib in Patients With Advanced Solid Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies capecitabine and celecoxib in treating patients with solid malignancies that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and celecoxib together may be an effective treatment for solid malignancies.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	capecitabine	Given PO
DRUG	celecoxib	Given PO
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacogenomic studies	Correlative studies

Timeline

• Start date: 2012-08-29
• Primary completion: 2016-02-10
• Completion: 2016-02-10
• First posted: 2012-10-12
• Last updated: 2018-05-30
• Results posted: 2018-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study