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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191763
First received: September 12, 2005
Last updated: November 5, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014