Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191256
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
June 2001
Not Provided
Pathological complete response rate, in previously untreated patients with clinical Stage I and II non-small cell lung cancer (NSCLC).
Same as current
Complete list of historical versions of study NCT00191256 on ClinicalTrials.gov Archive Site
Response rate, disease free survival,toxicities including pulmonary toxicity, operative mortality, and quality of life.
Response rate, disease free survival,toxicities including pulmonary toxicty, operative mortality, and quality of life.
Not Provided
Not Provided
 
Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer
Randomized Phase II Trial to Outline the Efficacy of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/Paclitaxel) When Used as Preoperative Chemotherapy In Patients With Stage I and II NSCLC

To evaluate the rate of complete pathological response after 3 cycles of gemcitabine containing chemotherapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non Small Cell Lung
  • Drug: Gemcitabine
  • Drug: Carboplatin
  • Drug: Paclitaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
July 2006
Not Provided

Inclusion Criteria:

  • Histologically or cytologically confirmed non small cell lung cancer
  • No prior chemotherapy or radiation for non small cell lung cancer
  • No prior malignancy

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Serious concomitant disorders
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00191256
5488, B9E-US-S235
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM 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