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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00078390
Recruitment Status : Unknown
Verified December 2004 by Shionogi.
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2004
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Non Small Cell Lung Cancer Drug: S-3304 Phase 1 Phase 2

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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.
Study Start Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078390


Locations
United States, California
Scripps Cancer Institute
La Jolla, California, United States, 92037
United States, District of Columbia
Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, New Jersey
VA Medical Center-East Orange (study available to veterans only)
East Orange, New Jersey, United States, 07108
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Shionogi
More Information

ClinicalTrials.gov Identifier: NCT00078390     History of Changes
Other Study ID Numbers: 0207P1421
First Posted: February 26, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2004

Keywords provided by Shionogi:
Non small cell lung cancer
Stage IIIA non small cell lung cancer
Stage IIIB non small cell lung cancer
Unresectable locally advanced non-small cell lung cancer
Lung cancer
Lung carcinoma
NSCLC
Stage III
chemotherapy
radiation
chemoradiation
matrix metalloproteinases
neovascularization
antiangiogenesis
type IV collagenases

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
S 3304
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action