Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non-Small-Cell Lung Carcinoma
Trial Information
Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/ GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Mexico: Federal Commission for Protection Against Health Risks
Study ID:
6952
NCT ID:
NCT00191620
Start Date:
March 2004
Completion Date:
May 2006
Related Keywords:
- Non-Small-Cell Lung Carcinoma
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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