A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
2 other identifiers
interventional
29
1 country
1
Brief Summary
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 lung-cancer
Started Dec 2004
Longer than P75 for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
October 6, 2014
CompletedOctober 6, 2014
October 1, 2014
8 years
September 12, 2005
September 25, 2014
October 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Every 35 days
Secondary Outcomes (3)
Time to Tumor Progression
Every 35 days
One Year Survival
one year
Pharmacokinetics
Cycle 2
Study Arms (1)
Docetaxel and Capecitabine
EXPERIMENTALInterventions
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.
36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tony Bekaii-Saablead
- Roche Pharma AGcollaborator
Study Sites (1)
Ohio State University
Columbus, Ohio, 43210, United States
Related Publications (1)
Bertino EM, Bekaii-Saab T, Fernandez S, Diasio RB, Karim NA, Otterson GA, Villalona-Calero MA. A phase II study of modulated-capecitabine and docetaxel in chemonaive patients with advanced non-small cell lung cancer (NSCLC). Lung Cancer. 2013 Jan;79(1):27-32. doi: 10.1016/j.lungcan.2012.09.013. Epub 2012 Oct 16.
PMID: 23079156RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tanios Bekaii-Saab, MD
- Organization
- The Ohio State University Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Bekaii-Saab
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
December 1, 2004
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
October 6, 2014
Results First Posted
October 6, 2014
Record last verified: 2014-10