A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Gemcitabine

Drug: docetaxel

Drug: cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191490

6549

B9E-IT-JHSC

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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