Back to resultsNeo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-Small-Cell-Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Gemcitabine
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell-Lung Cancer
Eligibility Criteria
Inclusion Criteria: define histologic or cytologic diagnosis of non small cell lung cancer. determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer. define performance status of 0-1 on ECOG scale do not have any prior tumor therapy to be suitable for curative resection Exclusion Criteria: to have any treatment within the last 30 days with any investigational drug. to get concurrent administration of any other tumor therapy to be pregnant to have poorly controlled diabetes mellitus to have 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 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Outcomes
Primary Outcome Measures
To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer
Secondary Outcome Measures
To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin
To determine the complete tumor resection rate
To evaluate overall survival and time to documented disease progression
Full Information
NCT ID
NCT00191763
First Posted
September 12, 2005
Last Updated
November 5, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00191763
Brief Title
Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer
Official Title
Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell-Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
cisplatin
Primary Outcome Measure Information:
Title
To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer
Secondary Outcome Measure Information:
Title
To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin
Title
To determine the complete tumor resection rate
Title
To evaluate overall survival and time to documented disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
define histologic or cytologic diagnosis of non small cell lung cancer.
determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer.
define performance status of 0-1 on ECOG scale
do not have any prior tumor therapy
to be suitable for curative resection
Exclusion Criteria:
to have any treatment within the last 30 days with any investigational drug.
to get concurrent administration of any other tumor therapy
to be pregnant
to have poorly controlled diabetes mellitus
to have 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 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer
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