NCT00736944

Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective: To determine the clinical CR rate (CR-p) at the primary tumor site to an IC regimen of weekly Abraxane and cetuximab with CF (ACCF) given for two cycles (over 6 weeks) in patients with locally advanced non-metastatic HNSCC. The assessment of primary tumor site response will be performed by the treating physician by careful clinical examination using WHO criteria. Radiographic studies will also be performed to assess primary tumor site response but will be used primarily to confirm lack of disease progression that may not be detected based on clinical examination alone. The secondary objectives include: * Document the clinical PR rate (PR-p) at the primary tumor site with this IC regimen * Document the clinical CR and PR rates at the involved regional nodes (CR-n and PR-n) with this IC regimen * Document the clinical overall CR rate (CR-o) (defined as achievement of a CR at the primary tumor site and at the involved regional nodes) and the clinical overall PR rate (PR-o) with this IC regimen * Document the CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates by FDG uptake on PET scan after this IC regimen * Document radiographic CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates as assessed by conventional CT scan using RECIST criteria after this IC regimen. * Correlate primary tumor site, nodal and overall tumor response rates based on WHO criteria of assessment with that based on CT scan and FDG-PET/CT. * Document and quantify SPARC expression by IHC in primary tumor tissue obtained at baseline in each patient and attempt to correlate these results with primary tumor site response to ACCF. * Document and grade AE's with this IC regimen with a pre-planned safety analysis after the first ten patients have completed the IC regimen. * Determine the overall survival (OS), disease-free survival (DFS), and progression-free survival (PFS) of this patient population.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Abraxane	100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3
DRUG	Cetuximab	400 mg/m2 IVPB, Day 1, cycle 1
DRUG	Cetuximab	250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3
DRUG	Cisplatin	75 mg/m2 IVPB Day 1, cycles 1, 2 and 3
DRUG	5-FU	750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3
RADIATION	Radiation (Post induction)	Monday-Friday, weeks 1-7
DRUG	Cisplatin	(Post induction) Cisplatin 100 mg/m2 IVPB on radiation day 1, 22 and 42
DRUG	Cetuximab	(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

Timeline

• Start date: 2008-12-19
• Primary completion: 2010-08-31
• Completion: 2020-07-06
• First posted: 2008-08-18
• Last updated: 2020-09-09
• Results posted: 2014-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study