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

Phase 2

• Conditions: Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: Pemetrexed

• Registration Number: NCT01333696
• Lead Sponsor: Fudan University

Brief 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-02
• Last Update Posted: 2013-03-05
• Primary Completion: 2013-04
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pemetrexed	Pemetrexed	500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity

Primary Outcome Measures

Name	Time	Method
Overall response rate	6 weeks

Secondary Outcome Measures

Name	Time	Method
Median progression-free survival	1 year
Median overall survival	1 year

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China