Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 5/4/2018 |
| Start Date: | February 2003 |
| End Date: | October 26, 2006 |
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 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.
conventional chemo-radiation 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.
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
- 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
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