Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer

Eli Lilly and Company1 site in 1 country64 target enrollmentMarch 2004

ConditionsNon-Small-Cell Lung Carcinoma

DrugsGemcitabine cisplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-Small-Cell Lung Carcinoma
Sponsor: Eli Lilly and Company
Enrollment: 64
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

May 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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