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

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.

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.

Inclusion Criteria:

• Age range: 18-65 years old
• Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
• Prior exposure of at least one line of platinum-containing regimen
• At least one site of measurable disease according to RECIST criteria
• ECOG performance status 0-1
• Life expectancy of more than 3 months
• Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
• Liver function: total bilirubin, ALT and AST <1.5×UNL
• Renal function: Cr<1.5×UNL, CCR≧45ml/min

Exclusion Criteria:

• With curable treatment option
• Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Significant active infection
• Pregnant or lactating women