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

This study has been completed.
Aventis Pharmaceuticals
Information provided by:
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
July 2002
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00191490 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: Gemcitabine
  • Drug: docetaxel
  • Drug: cisplatin
Not Provided
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Not Provided
Eli Lilly and Company
Aventis Pharmaceuticals
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP