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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2004 by Shionogi.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Shionogi

ClinicalTrials.gov Identifier:

NCT00078390

First received: February 24, 2004

Last updated: June 23, 2005

Last verified: December 2004

History of Changes

Purpose

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	Intervention	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Shionogi:

Estimated Enrollment:	90
Study Start Date:	February 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00078390 History of Changes
Other Study ID Numbers:	0207P1421
Study First Received:	February 24, 2004
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shionogi:

Lung cancer
Lung carcinoma
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
NSCLC
Stage III

chemotherapy
radiation
chemoradiation
matrix metalloproteinases
neovascularization
antiangiogenesis
type IV collagenases

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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