Back to resultsEfficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non Small Cell Lung
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Carboplatin
Paclitaxel
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 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
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Outcomes
Primary Outcome Measures
Pathological complete response rate, in previously untreated patients with clinical Stage I and II non-small cell lung cancer (NSCLC).
Secondary Outcome Measures
Response rate, disease free survival,toxicities including pulmonary toxicity, operative mortality, and quality of life.
Full Information
NCT ID
NCT00191256
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00191256
Brief Title
Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
To evaluate the rate of complete pathological response after 3 cycles of gemcitabine containing chemotherapy.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
Pathological complete response rate, in previously untreated patients with clinical Stage I and II non-small cell lung cancer (NSCLC).
Secondary Outcome Measure Information:
Title
Response rate, disease free survival,toxicities including pulmonary toxicity, operative mortality, and quality of life.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Chapel Hill
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer
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