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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00191763
First Posted: September 19, 2005
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00191763     History of Changes
Other Study ID Numbers: 7138
B9E-VI-S314
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: November 6, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs