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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191763

Purpose

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	Intervention	Phase
Carcinoma, Non-Small-Cell-Lung Cancer	Drug: Gemcitabine Drug: cisplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer

Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment:	52
Study Start Date:	November 2002
Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191763

Locations

Turkey
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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	7138, B9E-VI-S314
Study First Received:	September 12, 2005
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00191763
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Carcinoma
Naphazoline
Oxymetazoline
Cisplatin
Respiratory Tract Diseases
Guaifenesin

Lung Neoplasms
Phenylephrine
Lung Diseases
Phenylpropanolamine
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009