A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC.
Status:
Terminated
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
Trial Objectives:
The objective is to investigate the efficacy and safety of afatinib with induction
chemotherapy in primary unresected patients with locally advanced, HPV-negative, stage III or
IVa/b HNSCC including oral cavity, oropharynx, hypopharynx, or larynx.
Primary Objective Phase I The primary objective of the phase I portion of the trial is to
determine the maximum tolerated dose (MTD) or the recommended phase II dose of daily oral
afatinib that is safe in combination with carboplatin AUC 6 and paclitaxel 175mg/m2 q 21 days
as an induction regimen.
Primary Objective Phase 2 The primary objective of the phase 2 portion of the trial is to
estimate the objective tumor response rate and toxicity with induction therapy in patients
treated on the afatinib dose determined in Phase I.
Secondary Objectives The secondary objective of phase II is to estimate: 1) the overall
response to entire treatment after completion of CRT, 2) progression-free survival (PFS) rate
at 2 years, and 3) overall survival (OS) at 2 years.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
National Comprehensive Cancer Network Vanderbilt-Ingram Cancer Center