At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
Capecitabine +1 moredrug
Likely dose
Capecitabine 1250 mg/m² daily (divided as 625 mg/m² twice daily) on days 5–18 of each 28-day cycle; Docetaxel 36 mg/m² IV weekly for 3 weeks per 4-week cycleAI-extracted
Key inclusion· 6
- ✓Advanced (metastatic or locally advanced unresectable) NSCLC
- ✓No prior chemotherapy
- ✓ECOG performance status 0 or 1
- ✓Measurable disease by RECIST criteria
Key exclusion· 3
- ✕Pregnant or lactating women
- ✕Psychiatric disorders that would interfere with consent or follow-up
- ✕Uncontrolled diabetes mellitus (random blood sugar >250 mg/dL)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Capecitabine and Docetaxel for Lung Cancer and Non-Small-Cell Lung Carcinoma. Completed, enrolled 29 participants across 1 site.
Detailed Summary
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Non-Small-Cell Lung Carcinoma
CountriesUnited States
CollaboratorsRoche Pharma AG
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedSep 2005
Primary CompletionDec 2012
Study CompletionApr 2013
TodayJul 2026
First PostedSep 20, 2005
Enrollment StartDec 1, 2004
Primary CompletionDec 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 20.8 years ago
Interventions
Capecitabinedrug
1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxeldrug
36 mg/m2 IV weekly for 3 weeks every 4 weeks.