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Study of S-3304 in Patients with Locally Advanced Non-Small Cell Lung Cancer



Study of S-3304 in Patients with Locally Advanced Non-Small Cell Lung Cancer

For Condition: Non Small Cell Lung Cancer,Stage 3A non small cell lung cancer,Lung Cancer,Stage 3B non small cell lung cancer
Status: Recruiting
Sponsor(s): Shionogi ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 90

Location and Contact Information:

University of Kansas Cancer Center *Recruiting*
Kansas City,  Kansas,  66160
United States
Recruiting Rebecca  Clark-Snow 913-588-4714

The Cleveland Clinic *Recruiting*
Cleveland,  Ohio,  44195
United States
Recruiting Deb  Camino 216-445-3484

Scripps Cancer Institute *Recruiting*
La Jolla,  California,  92037
United States
Recruiting S-3304  Coordinator 858-882-8322

VA Medical Center-East Orange (study available to veterans only) *Recruiting*
East Orange,  New Jersey,  07108
United States
Recruiting Ilda  Boholli 973-395-7087

Lombardi Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Sharon  Levy 202-687-8921


Additional Information:
Study ID Numbers:
  0207P1421; 
Study Start Date: February 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078390

Other Stage 3b Non Small Cell Lung Cancer Studies:
1. Study of S-3304 in Patients with Locally Advanced Non-Small Cell Lung Cancer

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Study of S-3304 in Patients with Locally Advanced Non-Small Cell Lung Cancer

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