Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Completed
NCT Number: NCT00330044
Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer
To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.
To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions
Exclusion criteria
- Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy
Treatment and study plan
Premetrexed (Alimta)
Drugcarboplatin
DrugPrimary outcomes
-
Response and Progression Free Survival
Time frame: Up to five years after study completion
Sponsors and collaborators
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
Collaborators
- Eli Lilly and Company
Registry information
Official study title
A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.
Important dates
- Study start
- 2006
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- May 25, 2006
- Registry last updated
- May 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.