A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: Gemcitabine (Drug); Carboplatin (Drug)
Phase: Phase 3
Sponsored by: Eli Lilly and Company
Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin
versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
Official title: A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
To determine and compare the 1-year survival produced by combined Paraplatin (carboplatin) + Gemcitabine versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2
To determine the safety of combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2
To compare the response rate between treatment groups
To compare the changes in QOL between treatment groups
Minimum age: 18 Years.
Maximum age: N/A.
- Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically
positive pleural or pericardial effusion or Stage IV.
- No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of
- ECOG Performance Status of 2 .
- Patients must be at least 3 weeks since major surgery. Patients must be at least 1
week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy.
- Patients must have measurable disease, defined as lesions that can be accurately
measured in at least 1 dimension (longest diameter to be recorded) as greater than or
equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT
- Any prior radiation therapy to the thoracic area.
- Active and ongoing systemic infection.
- Prior radiation to greater than 25% of the bone marrow.
- ECOG PS other than 2
- Patients with a known hypersensitivity to gemcitabine and carboplatin.
Locations and Contacts
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., Dallas, Texas 75204, United States
Lilly Clinical Trial Registry
Starting date: March 2004
Ending date: August 2007
Last updated: November 10, 2007