Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00191763

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell-Lung Cancer	Drug: Gemcitabine Drug: cisplatin	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer

Study Start Date :

Nov 1, 2002

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.	Istanbul		Turkey

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Lilly Clinical Trial Registry

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00191763

Other Study ID Numbers:

7138
B9E-VI-S314

First Posted:

Sep 19, 2005

Last Update Posted:

Nov 6, 2007

Last Verified:

Nov 1, 2007

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Gemcitabine

Study Results

No Results Posted as of Nov 6, 2007