Status:
COMPLETED
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Lead Sponsor:
Tony Bekaii-Saab
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Lung Cancer
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.
Detailed Description
Rationale: Docetaxel has some efficacy against non-small cell lung cancer (NSCLC). This drug is Food and Drug Administration approved in combination with cisplatin (Platinol) for the treatment of unre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00201825
Start Date
December 1 2004
End Date
April 1 2013
Last Update
October 6 2014
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210