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

NCT01705106 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 12-1318NCI-2012-01704
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)

  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).

  Day 7 and 14 post treatment

Secondary Outcomes (4)

• CYP2C9 Genotype

  one week

• Response Rate

  Up to 2 years

• Drug-related Toxicities

  Up to six months

• PK Drug Interaction Model

  4 weeks

Study Arms (1)

Treatment (capecitabine, celecoxib)

EXPERIMENTAL

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.

Drug: capecitabine; Drug: celecoxib; Other: pharmacological study; Other: laboratory biomarker analysis; Other: pharmacogenomic studies

Interventions

capecitabine DRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda

Treatment (capecitabine, celecoxib)

celecoxib DRUG

Given PO

Also known as: Celebrex, SC-58635

Treatment (capecitabine, celecoxib)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (capecitabine, celecoxib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (capecitabine, celecoxib)

pharmacogenomic studies OTHER

Correlative studies

Also known as: Pharmacogenomic Study

Treatment (capecitabine, celecoxib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
• Histologically or cytologically confirmed solid tumor for which single agent capecitabine is an appropriate treatment option.
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
• Life expectancy \> 3 months
• Absolute neutrophil count (ANC) \>= l500/ul
• Hemoglobin \>= 9g/dL
• Platelets \>= 100,000/ul
• Creatinine within institutional normal limits or glomerular filtration rate \>= 50 mL/min/1.73 m\^2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation
• Total bilirubin \< 1.5 x upper limit of normal
• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) \< 2.5 x upper limit of normal for patients without liver metastases OR SGOT and SGPT \< 5 x upper limit of normal for patients with liver metastases
• Measurable or non-measurable disease will be allowed
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, up until 30 days after final study treatment; should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately
• Patients taking substrates of CYP2C9 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with the study drugs
• Signed informed consent

You may not qualify if:

• Prior treatment with capecitabine and/or celecoxib is allowed; however, patients with a documented history (at the time of enrollment) of \>= grade 3 toxicities with capecitabine or celecoxib are excluded
• Patients taking any of the following drugs are excluded: inducers or inhibitors of CYP2C9, warfarin, aspirin, corticosteroids, or non-steroidal anti-inflammatory drugs (NSAIDs)
• History of myocardial infarction or stroke within the last 6 months, or history of uncontrolled cardiovascular or cerebrovascular disease; a 12-lead electrocardiogram (ECG) will be performed during the screening period
• History of perforation or bleeding related to peptic ulcer disease
• History of hypersensitivity or allergy to study drugs, aspirin, sulfonamides, or NSAIDs
• Known poor metabolizers of CYP2C9 substrates
• Known deficiency of dihydropyrimidine dehydrogenase (DPD)
• Patients who have had chemotherapy, immunotherapy, or investigational anti-cancer therapy within 4 weeks of starting study drug, or radiotherapy within 14 days of starting study drug, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer)
• Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment; similarly, any unstable medical condition that in the opinion of the treating physician or study investigators, would interfere with determination of the study objectives
• Pregnancy or breastfeeding
• Major surgery within 4 weeks

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

Related Publications (1)

• Wood K, Byron E, Janisch L, Salgia R, Sharma MR. Capecitabine and Celecoxib as a Promising Therapy for Thymic Neoplasms. Am J Clin Oncol. 2018 Oct;41(10):963-966. doi: 10.1097/COC.0000000000000400.

  PMID: 28654574 DERIVED

MeSH Terms

Interventions

Capecitabine; Celecoxib; Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Manish R. Sharma, MD
• Organization: University of Chicago

msharma@bsd.uchicago.edu

773-834-0312

Study Officials

• Manish R. Sharma, M.D.

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 12, 2012
• Study Start: August 29, 2012
• Primary Completion: February 10, 2016
• Study Completion: February 10, 2016
• Last Updated: May 30, 2018
• Results First Posted: May 30, 2018

Record last verified: 2018-04

Locations

US (1)