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Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00191620
First Posted: September 19, 2005
Last Update Posted: January 26, 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
September 12, 2005
September 19, 2005
January 26, 2007
March 2004
Not Provided
To evaluate the objective response rate (ORR) of the standard (30 minute infusion) versus a fixed dose rate (10 mg/m2/minute) of gemcitabine combined with cisplatin as treatment for advanced NSCLC after treatment completion.
Same as current
Complete list of historical versions of study NCT00191620 on ClinicalTrials.gov Archive Site
  • To evaluate progression-free survival of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for advanced NSCLC.
  • To evaluate incidence of laboratory and non laboratory adverse events by maximum Common Toxicity Criteria (CTC) toxicity grade and relationship to study drug of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for
Same as current
Not Provided
Not Provided
 
Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.
Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer

The purposes of this study are to determine:

How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer.

The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
  • Drug: Gemcitabine
  • Drug: cisplatin
Not Provided
Pereira JR, Fein L, Del Giglio A, Blajman CR, Richardet E, Schwartsmann G, Orlando M, Hall BJ, West TM, van Kooten M. Gemcitabine administered as a short infusion versus a fixed dose rate in combination with cisplatin for the treatment of patients with advanced non-small cell lung cancer. Lung Cancer. 2007 Oct;58(1):80-7. Epub 2007 Jun 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
May 2006
Not Provided

Inclusion Criteria:

  • At least 18 years of age
  • Histologically or cytologically confirmed diagnosis of NSCLC
  • Have provided written informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC
  • Presence of uncontrolled central nervous system (CNS) metastases
  • Inability to comply with protocol or study procedures
  • Pregnancy
  • Breast feeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Chile,   Mexico
 
 
NCT00191620
6952
B9E-LA-S350
Not Provided
Not Provided
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP