At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trial to Determine the CR Rate at the Primary Tumor Site After 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head & Neck Carcinoma Treated With Definitive Concurrent Cisplatin & Radiation Therapy
In Brief
A Phase 2 clinical trial evaluating Abraxane, Cetuximab, and 3 other interventions for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This phase two trial will determine the tumor response rate at the primary site and at involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.
Study Details
Timeline
Interventions
100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3
400 mg/m2 IVPB, Day 1, cycle 1
250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3
75 mg/m2 IVPB Day 1, cycles 1, 2 and 3
750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3
Monday-Friday, weeks 1-7
(Post induction) Cisplatin 100 mg/m2 IVPB on radiation day 1, 22 and 42
(Post-induction) Cetuximab (for patients who cannot receive cisplatin) will begin (+/- 3 days) before starting radiation therapy at 400 mg/m2 IVPB. Subsequent doses of cetuximab will be given weekly at 250 mg/m2 IVPB