Trial · NCT01705106
Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies
NCT01705106, Phase 1, Terminated, University of Chicago; results first posted 2018-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies. Trials, record NCT01705106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01705106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies
- NCT number
- NCT01705106
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- capecitabine, celecoxib, pharmacological study, laboratory biomarker analysis, pharmacogenomic studies
- First posted
- 2012-10-12
- Last updated
- 2018-05-30
- Results first posted
- 2018-05-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7) | 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). |
| Secondary | CYP2C9 Genotype | 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. |
| Secondary | Response Rate | Up to 2 years | Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate. |
| Secondary | Drug-related Toxicities | Up to six months | Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity. |
| Secondary | PK Drug Interaction Model | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7) | Day 7 and 14 post treatment | The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected. | ||
| SECONDARY | CYP2C9 Genotype | one week | The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected. | ||
| SECONDARY | Response Rate | Up to 2 years | The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected. | ||
| SECONDARY | Drug-related Toxicities | Up to six months | The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected. | ||
| SECONDARY | PK Drug Interaction Model | 4 weeks | The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Capecitabine, Celecoxib) | 21 | |
| Overall Study | COMPLETED | Treatment (Capecitabine, Celecoxib) | 21 | |
| Overall Study | NOT COMPLETED | Treatment (Capecitabine, Celecoxib) | 0 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Treatment (Capecitabine, Celecoxib) | 5 | 21 | |
| other | Agitation | Psychiatric disorders | Treatment (Capecitabine, Celecoxib) | 1 | 21 | |
| other | Anal hemorrhage | Gastrointestinal disorders | Treatment (Capecitabine, Celecoxib) | 1 | 21 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Capecitabine, Celecoxib) | 1 | 21 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Capecitabine, Celecoxib) | 9 | 21 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment (Capecitabine, Celecoxib) | 1 | 21 | |
| other | Blood bilirubin increased, intermittent (Gilbert's syndrome) | Investigations | Treatment (Capecitabine, Celecoxib) | 1 | 21 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Treatment (Capecitabine, Celecoxib) | 1 | 21 | |
| other | Bullous dermatitis (on heels from treadmill) | Skin and subcutaneous tissue disorders | Treatment (Capecitabine, Celecoxib) | 1 | 21 | |
| other | Cataract, right eye | Eye disorders | Treatment (Capecitabine, Celecoxib) | 1 | 21 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Capecitabine, Celecoxib) | ||
| Total, other adverse events | Treatment (Capecitabine, Celecoxib) | 20 | 21 |
| Total, serious adverse events | Treatment (Capecitabine, Celecoxib) | 9 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28654574 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01705106
GET https://conductscience.org/api/trials/v1/NCT01705106/events?page=2