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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:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191620
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes

September 12, 2005
January 24, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years and older
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
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