Back to resultsA Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Gemcitabine
docetaxel
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion criteria Histologically or cytologically confirmed diagnosis of NSCLC Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System Patients must have at least one measurable lesion WHO Performance Status 0 or 1 Adequate Organ Function Exclusion criteria: Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments Prior radiotherapy for NSCLC Patients with symptomatic brain metastases or with leptomeningeal disease. However, patients with symptomatic brain metastases who become asymptomatic under corticosteroids treatment can enter the study Current peripheral neuropathy NCI grade 2
Sites / Locations
- 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
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00191490
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
Collaborators
Aventis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00191490
Brief Title
A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
Official Title
A Multicenter Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel (RP56976, TAXOTERE *) and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Aventis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
cisplatin
Primary Outcome Measure Information:
Title
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
Title
cisplatin /gemcitabine
Secondary Outcome Measure Information:
Title
To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.
Title
To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Histologically or cytologically confirmed diagnosis of NSCLC
Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System
Patients must have at least one measurable lesion
WHO Performance Status 0 or 1
Adequate Organ Function
Exclusion criteria:
Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments
Prior radiotherapy for NSCLC
Patients with symptomatic brain metastases or with leptomeningeal disease. However, patients with symptomatic brain metastases who become asymptomatic under corticosteroids treatment can enter the study
Current peripheral neuropathy NCI grade 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Chair
Facility Information:
Facility Name
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
City
Sesto Fiorentino
State/Province
Florence
ZIP/Postal Code
50019
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
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