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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489996
• Other study ID #: 6672
• Secondary ID: B9E-GH-JHSE
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: January 2003
• Est. completion date: June 2005

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• gemcitabine

• cisplatin

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate response rate
Secondary	Evaluate time to progression
Secondary	Evaluate toxicities
Secondary	Evaluate survival

External Links

•   Lilly Clinical Trial Registry