NCT00882583

A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC

A Phase I Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in Locally Advanced Squamous Cell Carcinoma of Head and Neck (HNSCC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8
DRUG	Dasatinib	Oral Dasatinib Days 8 through 64.
DRUG	Cisplatin	Q 3 weeks (Days 15, 36 and 57): +/- 3 Days
RADIATION	Radiation Therapy	Standard Radiation Therapy.

Timeline

• Start date: 2009-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2009-04-16
• Last updated: 2019-01-09
• Results posted: 2017-02-23

Locations

2 sites across 1 country: United States