NCT01333696

Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

Detailed description

The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2011-04-12
• Last updated: 2013-03-05

Locations

1 site across 1 country: China