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

Phase 2CompletedNCT00191620

Eli Lilly and Company64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

GemcitabineDRUG

cisplatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Buenos Aires, Argentina

São Paulo, Brazil

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

Data from ClinicalTrials.gov

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