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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: capecitabine
Drug: celecoxib
Other: pharmacological study
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
57.5
(52 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
5
  23.8%
Male
16
  76.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   4.8%
White
19
  90.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)
Hide Description 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).
Time Frame Day 7 and 14 post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description:

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title CYP2C9 Genotype
Hide Description 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.
Time Frame one week
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description:

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Response Rate
Hide Description Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description:

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Drug-related Toxicities
Hide Description Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.
Time Frame Up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description:

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title PK Drug Interaction Model
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description:

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Patients were followed for 30 days post treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Capecitabine, Celecoxib)
Hide Arm/Group Description

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.

capecitabine: Given PO

celecoxib: Given PO

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

pharmacogenomic studies: Correlative studies

All-Cause Mortality
Treatment (Capecitabine, Celecoxib)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Capecitabine, Celecoxib)
Affected / at Risk (%)
Total   9/21 (42.86%) 
Cardiac disorders   
Chest pain   1/21 (4.76%) 
Gastrointestinal disorders   
Diarrhea   2/21 (9.52%) 
Small intestinal obstruction   2/21 (9.52%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorder - Other, specify   1/21 (4.76%) 
Nervous system disorders   
Seizure   1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders - Other (Pneumonia)   2/21 (9.52%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome   1/21 (4.76%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Capecitabine, Celecoxib)
Affected / at Risk (%)
Total   20/21 (95.24%) 
Blood and lymphatic system disorders   
Anemia   1/21 (4.76%) 
Cardiac disorders   
Tachycardia   1/21 (4.76%) 
Eye disorders   
Cataract, right eye   1/21 (4.76%) 
Gastrointestinal disorders   
Abdominal Pain   5/21 (23.81%) 
Anal hemorrhage   1/21 (4.76%) 
Constipation   2/21 (9.52%) 
Diarrhea   11/21 (52.38%) 
Gastrointestinal disorders - Other (Excessive saliva)   1/21 (4.76%) 
Lip pain   1/21 (4.76%) 
Mucositis   4/21 (19.05%) 
Mucositis oral   2/21 (9.52%) 
Nausea   8/21 (38.10%) 
Oral dysesthesia, intermittent   1/21 (4.76%) 
Proctitis   1/21 (4.76%) 
Stomach pain   1/21 (4.76%) 
Vomiting   4/21 (19.05%) 
General disorders   
Fatigue   12/21 (57.14%) 
Fever   1/21 (4.76%) 
Non-cardiac chest pain   1/21 (4.76%) 
Pain, intermittent left sided pain   1/21 (4.76%) 
Pain, left shoulder   1/21 (4.76%) 
Pain, Right shoulder pain   1/21 (4.76%) 
Infections and infestations   
Eye infection, left eye staph infection   1/21 (4.76%) 
Infections and infestations - Other (Black thrush)   1/21 (4.76%) 
Infections and infestations - Other (Oral thrush)   1/21 (4.76%) 
Infections and infestations - Other (Right hand laceration)   1/21 (4.76%) 
Lip infection, herpes skin lesion upper lip   1/21 (4.76%) 
Nail infection   1/21 (4.76%) 
Papulopustular rash, hands   1/21 (4.76%) 
Paronychia   1/21 (4.76%) 
Urinary tract infection   1/21 (4.76%) 
Injury, poisoning and procedural complications   
Fall   1/21 (4.76%) 
Injury, poisoning and procedural complications - Other (Pulled posterior left chest wall muscle)   1/21 (4.76%) 
Investigations   
Blood bilirubin increased, intermittent (Gilbert's syndrome)   1/21 (4.76%) 
Creatinine increased   1/21 (4.76%) 
Neutrophil count decreased   1/21 (4.76%) 
Platelet count decreased   3/21 (14.29%) 
Weight loss   2/21 (9.52%) 
Metabolism and nutrition disorders   
Anorexia   9/21 (42.86%) 
Hypercalcemia   1/21 (4.76%) 
Hypokalemia   1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Back pain   1/21 (4.76%) 
Bone pain   1/21 (4.76%) 
Flank pain, right   1/21 (4.76%) 
Neck pain   1/21 (4.76%) 
Pain in extremity   2/21 (9.52%) 
Nervous system disorders   
Dizziness   2/21 (9.52%) 
Dysgeusia   3/21 (14.29%) 
Headache, intermittent   1/21 (4.76%) 
Paresthesia, right arm   1/21 (4.76%) 
Paresthesia, Right eye over cheek   1/21 (4.76%) 
Peripheral sensory neuropathy   4/21 (19.05%) 
Tremor, hands   1/21 (4.76%) 
Psychiatric disorders   
Agitation   1/21 (4.76%) 
Insomnia   3/21 (14.29%) 
Psychiatric disorders - Other (rage/altered mental status)   1/21 (4.76%) 
Renal and urinary disorders   
Hematuria   1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Cough   3/21 (14.29%) 
Dyspnea   7/21 (33.33%) 
Hypoxia   1/21 (4.76%) 
Pleural effusion   1/21 (4.76%) 
Postnasal drip, intermittent   2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders - Other (Pneumonia)   2/21 (9.52%) 
Sore throat   1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Bullous dermatitis (on heels from treadmill)   1/21 (4.76%) 
Dry skin, palms   1/21 (4.76%) 
Palmar-plantar erythrodysesthesia syndrome   12/21 (57.14%) 
Rash, back and hands   1/21 (4.76%) 
Rash, forearms   1/21 (4.76%) 
Rash, scrotum   1/21 (4.76%) 
Skin and subcutaneous tissue disorders - Other (hypochromic lesions chest/nipples)   1/21 (4.76%) 
Skin and subcutaneous tissue disorders - Other (Night sweats)   1/21 (4.76%) 
"Skin and subcutaneous tissue disorders - Other (Skin lesion right shoulder)"   1/21 (4.76%) 
Skin hyperpigmentation   1/21 (4.76%) 
Surgical and medical procedures   
Thromboembolic event (pulmonary embolism)   1/21 (4.76%) 
Vascular disorders   
Hot flashes   1/21 (4.76%) 
Hypertension   1/21 (4.76%) 
Hypotension, orthostatic   1/21 (4.76%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manish R. Sharma, MD
Organization: University of Chicago
Phone: 773-834-0312
EMail: msharma@bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01705106     History of Changes
Other Study ID Numbers: 12-1318
NCI-2012-01704 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 8, 2012
First Posted: October 12, 2012
Results First Submitted: February 14, 2018
Results First Posted: May 30, 2018
Last Update Posted: May 30, 2018