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Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00191230
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell lung cancer

Condition or disease Intervention/treatment Phase
Carcinoma, Non Small Cell Lung Drug: gemcitabine Drug: carboplatin Drug: cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/ Cisplatin)When Used as Preoperative Chemotherapy for Patients With Stage I and II NSCLC
Study Start Date : September 2001
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Complete pathological response

Secondary Outcome Measures :
  1. Response rate, disease free survival, toxicity including pulmonary toxicity,operative mortality and quality of life.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically of cytologically confirmed non small cell lung cancer
  • No prior chemotherapy or radiation
  • No prior malignancy

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Serious concomitant systemic disorder

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): NCT00191230


Locations
United States, North Carolina
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 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chapel Hill, North Carolina, United States
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

ClinicalTrials.gov Identifier: NCT00191230     History of Changes
Other Study ID Numbers: 5489
B9E-US-S236
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Carboplatin
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