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.
18 Years
85 Years
Both
Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer
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 Center | Washington, District of Columbia 20007 |
| Scripps Cancer Institute | La Jolla, California 92037 |
| University of Kansas Cancer Center | Kansas City, Kansas 66160 |
| VA Medical Center-East Orange (study available to veterans only) | East Orange, New Jersey 07108 |
| The Cleveland Clinic | Cleveland, Ohio 44195 |
