Conditions: Squamous Cell Carcinoma
Keywords: Head and Neck Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Patients will receive Azacitidine and cisplatin.

Interventions: intervention 1: Azacitidine intervention 2: Cisplatin
Intervention descriptions: intervention 1: SC azacitidine intervention 2: cisplatin 75 mg/m\^2 day 8 every 28 days

Protocol document: