NCT00787852

A Study of Dasatinib With Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer (NSCLC)

A Phase I Study of Dasatinib With Concurrent Chemoradiation for Stage III NSCLC Principal Investigator: Howard Safran, MD.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III NSCLC in separate cohorts of locally advanced and potentially resectable disease.

Detailed description

Describe the safety of maintenance dasatinib, 100 mg/day for 2 years, in patients with stage III NSCLC. For patients with potentially resectable disease, to assess the pathologic complete response following neoadjuvant dasatinib, paclitaxel, carboplatin and 50.4 Gy concurrent radiation. For patients with locally unresectable disease, to obtain radiographic response data following dasatinib, paclitaxel, carboplatin and 64.8 Gy radiation.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47	Locally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years\*
DRUG	Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38	Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years\*

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-03-01
• Completion: 2011-12-01
• First posted: 2008-11-10
• Last updated: 2014-07-30
• Results posted: 2013-09-25

Locations

1 site across 1 country: United States