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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2013

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.

Interventions

  • Drug: Pemetrexed
    • Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks

Arms, Groups and Cohorts

  • Experimental: Pemetrexed
    • 500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity

Clinical Trial Outcome Measures

Primary Measures

  • Overall response rate
    • Time Frame: 6 weeks

Secondary Measures

  • Median progression-free survival
    • Time Frame: 1 year
  • Median overall survival
    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ye Guo, Dr. – Fudan University
  • Overall Official(s)
    • Ye Guo, MD, Principal Investigator, Fudan University
  • Overall Contact(s)
    • Ye Guo, MD, 86 21 64175590, pattrick_guo@msn.com

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