Clinical trial NCT00787852
Conditions: Non-Small Cell Lung Cancer
Keywords: dasatinib radiation paclitaxel carboplatin NSCLC safety addition of dasatinib to chemo RT stage III NSCLC
Sponsor: Brown University
Start date: 2009-03-01; Completion date: 2011-12-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: 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\* arm 2: 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\*
Interventions: intervention 1: Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47 intervention 2: Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38
Intervention descriptions: intervention 1: 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\* intervention 2: 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\*

Protocol documents: