Status:
COMPLETED
A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00191490
Start Date
July 1 2002
End Date
May 1 2005
Last Update
January 26 2007
Active Locations (1)
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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, 50019