A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00191490
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the evaluation of the pathological complete response after 8 instillation of gemcitabine. 46 patients are requested.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess the antitumour activity as measured by response rate in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine
- Secondary Outcome Measures
Name Time Method To determine time to progression, duration of response, time to treatment failure, and overall survival in each group. To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 am to 5:00 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician
🇮🇹Sesto Fiorentino, Florence, Italy