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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Gemcitabine

Criteria

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