18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate of Complete or Partial ResponsePrimary· At 15 weeks
The response rates of complete or partial response rate as defined by the Response Evaluation Criteria for Solid Tumors at 15 weeks of a chemotherapy regimen involving docetaxel and capecitabine as front line therapy at 95% confidence interval. Complete Response (CR): the disappearance of all target lesions Partial Response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Group
Value
95% CI
Treatment (Docetaxel, Capecitabine)
1
Progression-free SurvivalSecondary· First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 5 years
The Kaplan-Meier method will be used to estimate time to event distributions for progression-free survival. Progression-free survival will be defined as from the first date of therapy until the first notation of clinical progression, relapse or death from any cause.
Group
Value
95% CI
Treatment (Docetaxel, Capecitabine)
211
63 – 327
SurvivalSecondary· First date of therapy until the date of death from any cause, assessed up to 5 years
The Kaplan-Meier method will be used to estimate time to event distributions for survival. Survival will be defined as from the first date of therapy until the date of death from any cause.
Group
Value
95% CI
Treatment (Docetaxel, Capecitabine)
264.5
147 – 516
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Docetaxel, Capecitabine)
Serious: 10/14 (71%)
Deaths: 5/14
Serious adverse events (16 terms)
Reaction
System
Treatment (Docetaxel, Cape…
febrile nuetropenia
Blood and lymphatic system disorders
—
White blood cell decreased
Investigations
—
Mucositis, oral
Gastrointestinal disorders
—
Neutrophil count decreased
Investigations
—
dyspnea
Respiratory, thoracic and mediastinal disorders
—
Anemia
Blood and lymphatic system disorders
—
dysphagia
Gastrointestinal disorders
—
Gastrointestinal disorder, Other
Gastrointestinal disorders
—
Abdominal infection
Infections and infestations
—
hypocalcemia
Metabolism and nutrition disorders
—
vomiting
Gastrointestinal disorders
—
Urinary tract infection
Infections and infestations
—
hypoglycemia
Metabolism and nutrition disorders
—
Non-cardiac chest pain
General disorders
—
Respiratory, thoracic and mediastinal disorders, Other
This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
Last refreshed: 8 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02524275.