Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.
Phase 2
Completed
- Conditions
- Non-Small-Cell Lung Carcinoma
- Registration Number
- NCT00191620
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
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
🇲🇽Mexico City, Mexico