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

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Squamous Cell Carcinoma of Head and Neck

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT01333696

HNTG 11-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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