Trial Outcomes & Findings for Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies (NCT NCT01705106)
NCT ID: NCT01705106
Last Updated: 2018-05-30
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Day 7 and 14 post treatment
Results posted on
2018-05-30
Participant Flow
Participant milestones
| Measure |
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.
capecitabine: Given PO
celecoxib: Given PO
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
pharmacogenomic studies: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies
Baseline characteristics by cohort
| Measure |
Treatment (Capecitabine, Celecoxib)
n=21 Participants
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
|
|---|---|
|
Age, Continuous
|
57.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7 and 14 post treatmentPopulation: The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one weekPopulation: The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to six monthsPopulation: The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Capecitabine, Celecoxib)
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Capecitabine, Celecoxib)
n=21 participants at risk
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
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Cardiac disorders
Chest pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other (Pneumonia)
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Seizure
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
Other adverse events
| Measure |
Treatment (Capecitabine, Celecoxib)
n=21 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
23.8%
5/21 • Patients were followed for 30 days post treatment.
|
|
Psychiatric disorders
Agitation
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
9/21 • Patients were followed for 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Investigations
Blood bilirubin increased, intermittent (Gilbert's syndrome)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis (on heels from treadmill)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Eye disorders
Cataract, right eye
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
3/21 • Patients were followed for 30 days post treatment.
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
52.4%
11/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin, palms
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
3/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
7/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Eye infection, left eye staph infection
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
General disorders
Fatigue
|
57.1%
12/21 • Patients were followed for 30 days post treatment.
|
|
General disorders
Fever
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain, right
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other (Excessive saliva)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Headache, intermittent
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Renal and urinary disorders
Hematuria
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Vascular disorders
Hot flashes
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Vascular disorders
Hypotension, orthostatic
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Infections and infestations - Other (Black thrush)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Infections and infestations - Other (Oral thrush)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Infections and infestations - Other (Right hand laceration)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other (Pulled posterior left chest wall muscle)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
14.3%
3/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Lip infection, herpes skin lesion upper lip
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Lip pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Mucositis
|
19.0%
4/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Nail infection
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
38.1%
8/21 • Patients were followed for 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Investigations
Neutrophil count decreased
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Oral dysesthesia, intermittent
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
General disorders
Pain, intermittent left sided pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
General disorders
Pain, left shoulder
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
General disorders
Pain, Right shoulder pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
57.1%
12/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Papulopustular rash, hands
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Paresthesia, right arm
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Paresthesia, Right eye over cheek
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Paronychia
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.0%
4/21 • Patients were followed for 30 days post treatment.
|
|
Investigations
Platelet count decreased
|
14.3%
3/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip, intermittent
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Proctitis
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Psychiatric disorders
Psychiatric disorders - Other (rage/altered mental status)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash, back and hands
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash, forearms
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash, scrotum
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other (Pneumonia)
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other (hypochromic lesions chest/nipples)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other (Night sweats)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
"Skin and subcutaneous tissue disorders - Other (Skin lesion right shoulder)"
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Cardiac disorders
Tachycardia
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Surgical and medical procedures
Thromboembolic event (pulmonary embolism)
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Nervous system disorders
Tremor, hands
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Patients were followed for 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Patients were followed for 30 days post treatment.
|
|
Investigations
Weight loss
|
9.5%
2/21 • Patients were followed for 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place