Status:
COMPLETED
A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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 NSCLC.
- 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 scan.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00190710
Start Date
March 1 2004
End Date
August 1 2007
Last Update
November 14 2007
Active Locations (1)
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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.
Dallas, Texas, United States, 75204