Conditions: Head and Neck Neoplasms
Keywords: Pharynx Larynx Nose Parathyroid
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 69
Healthy volunteers: no

Brief summary:
The purpose of this study is to look for an improvement in progression free survival with the combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck.

Detailed description:

Arms:
arm 1: Cycle 1:

Week 1 - Cetuximab 400 milligrams/square meter (mg/m²) on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin area under curve (AUC) 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Cycle 2-6:

Week 1 - Cetuximab 250 mg/m² on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin AUC 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Following Cycle 6, Cetuximab Monotherapy: 250 mg/m² intravenously weekly on Day 1

Interventions: intervention 1: Pemetrexed intervention 2: Cetuximab intervention 3: Carboplatin intervention 4: Cisplatin
Intervention descriptions: intervention 1: Administered intravenously, for maximum of 6 cycles. intervention 2: Administered intravenously in combination therapy, for a maximum of 6 cycles.

After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression. intervention 3: Administered intravenously, for a maximum of 6 cycles intervention 4: Administered intravenously, for a maximum of 6 cycles

Protocol document: