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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.


Phase 1/Phase 2
18 Years
85 Years
Open (Enrolling)
Both
Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer

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Trial Information

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.


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

0207P1421

NCT ID:

NCT00078390

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • Lung Cancer
  • Stage IIIA Non Small Cell Lung Cancer
  • Stage IIIB Non Small Cell Lung Cancer
  • Lung cancer
  • Lung carcinoma
  • Non small cell lung cancer
  • Stage IIIA non small cell lung cancer
  • Stage IIIB non small cell lung cancer
  • NSCLC
  • Stage III
  • chemotherapy
  • radiation
  • chemoradiation
  • matrix metalloproteinases
  • neovascularization
  • antiangiogenesis
  • type IV collagenases
  • Unresectable locally advanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Lombardi Cancer CenterWashington, District of Columbia  20007
Scripps Cancer InstituteLa Jolla, California  92037
University of Kansas Cancer CenterKansas City, Kansas  66160
VA Medical Center-East Orange (study available to veterans only)East Orange, New Jersey  07108
The Cleveland ClinicCleveland, Ohio  44195