Phase 2
Completed N=29
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Source: ClinicalTrials.gov NCT00201825 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Oct 2014
Primary outcomePrimary: Determine Objective Response Rate — 0; 5; 14; 9 patients
Summary
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine Objective Response Rate |
0; 5; 14; 9; 5 | — |
| SECONDARY Time to Tumor Progression |
3.3 | — |
| SECONDARY One Year Survival |
10.5 | — |
| SECONDARY Pharmacokinetics |
— | — |
Eligibility Criteria
Inclusion Criteria
- Must have advanced NSCLC
- No prior chemotherapy
- Eastern Cooperative Oncology Group(ECOG)Performance Status:0 or 1
- Must have measurable disease (RECIST criteria)
- life expectancy of at least 12 weeks
- adequate organ function including
Exclusion Criteria
- Pregnant or lactating women
- Psychiatric disorders that would interfere w/consent or follow-up
- Patients with uncontrolled diabetes mellitus, defined as random blood sugar > 250mg/dL.
Data sourced from ClinicalTrials.gov (NCT00201825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.