Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Conditions||non small cell lung cancer, lung cancer, stage iiia non small cell lung cancer, stage iiib non small cell lung cancer|
|Phase||phase 1/phase 2|
|Start date||February 2003|
|Trial size||90 participants|
|Trial identifier||NCT00078390, 0207P1421|
A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|La Jolla, CA||Scripps Cancer Institute||no longer recruiting|
|Washington D.C., DC||Lombardi Cancer Center||no longer recruiting|
|Kansas City, KS||University of Kansas Cancer Center||no longer recruiting|
|East Orange, NJ||VA Medical Center-East Orange (study available to veterans only)||no longer recruiting|
|Cleveland, OH||The Cleveland Clinic||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Male or female participants from 18 years up to 85 years old.
INCLUSION CRITERIA - newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion - ECOG performance status 0-1 - adequate organ function - clinically indicated and able to receive conventional chemoradiation therapy EXCLUSION CRITERIA - patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment - patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment
|Official title||A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-Small Cell Lung Cancer.|
|Description||A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.|
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