NCT00443261

Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase I Study of Azacitidine in Combination With Cisplatin Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN).

Detailed description

Open-label, non-randomized and dose escalation study in which groups of 3-6 patients with squamous cell carcinoma of the head and neck will receive sequentially increased dosages of azacitidine SC injection in combination with a fixed dose of cisplatin IV injection until dose-limiting toxicity is demonstrated in 2 of the 6 patients.

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Azacitidine	SC azacitidine
DRUG	Cisplatin	cisplatin 75 mg/m\^2 day 8 every 28 days

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-03-05
• Last updated: 2017-02-27
• Results posted: 2017-02-27

Locations

1 site across 1 country: United States