Conditions: Head and Neck Cancer
Keywords: HNSCC Dasatinib Cetuximab Cisplatin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
Primary Objective for Phase I

1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination with cetuximab/RT in Cohort A.
2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT in Cohort B

Detailed description:
Primary Objective for Phase I

1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination with cetuximab/RT in Cohort A, in patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx.
2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT in Cohort B, in patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, and larynx.

Arms:
arm 1: In Cohort A , there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib at specific dose level from day 8-14.

Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib at specific dose level in combination with cetuximab 250mg/m2 IV and radiation therapy (RT) 70Gy at 2Gy/fn. arm 2: In Cohort B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib at specific dose level from day 8-14.

Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib at specific dose level, in combination with q 3 week cisplatin 75mg/m2, weekly cetuximab 250mg/m2 IV and RT 70Gy ( 2gy per fraction).

Interventions: intervention 1: Cetuximab intervention 2: Dasatinib intervention 3: Cisplatin intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 intervention 2: Oral Dasatinib Days 8 through 64. intervention 3: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days intervention 4: Standard Radiation Therapy.

Protocol document: