Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
Conditions
Squamous Cell Carcinoma of Head and Neck
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
Squamous cell carcinoma of head and neck, Pemetrexed
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pemetrexed
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Fudan University Shanghai Cancer Center
Shanghai, China
Status: Recruiting
Contact: Ye Guo, MD - 86 21 64175590 - pattrick_guo@msn.com
Start Date
April 2011
Completion Date
June 2013
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page