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Trial Comparing 3 and 4 Week Regimen of Gemcitabine and Cisplatin in Patients With Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489996
First Posted: June 22, 2007
Last Update Posted: June 22, 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
The purpose of this study is to evaluate response rate of the 3 week versus 4 week treatment of gemcitabine with cisplatin as the first line treatment for non-small cell lung cancer patients in China.

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: gemcitabine Drug: cisplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Trial Comparing a Combined Gemcitabine and Cisplatin 3-Week Regimen With a 4-Week Regimen in Non-Small Cell Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Evaluate response rate

Secondary Outcome Measures:
  • Evaluate time to progression
  • Evaluate toxicities
  • Evaluate survival

Enrollment: 100
Study Start Date: January 2003
Study Completion Date: June 2005
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic diagnosis of NSCLC
  • Presence of Stage IIIB or Stage IV disease
  • Patients must have received no prior systemic chemotherapy
  • Patients must have at least one bi-dimensionally measurable lesion with clearly defined margins and two perpendicular diameters that are clearly measurable by any of the following: chest x-ray, with at least one diameter 1.0 cm or greater, CT, with both diameters greater than the distance between cuts of the imaging study, palpation, with both diameters 2.0 cm or greater, or disease progressing in areas of prior radiation therapy may be included
  • No prior radiotherapy for the target organ, no other radiotherapy for at least 2 weeks prior to study enrollment and the patient must have fully recovered from all acute toxic effects of the treatment.

Exclusion Criteria:

  • Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Lilly employees may participate in Lilly sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have previously completed or withdrawn from this study or any other study investigating gemcitabine.
  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): NCT00489996


Locations
China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shanghai, China
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: NCT00489996     History of Changes
Other Study ID Numbers: 6672
B9E-GH-JHSE
First Submitted: June 20, 2007
First Posted: June 22, 2007
Last Update Posted: June 22, 2007
Last Verified: June 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