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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01333696
• Other study ID #: HNTG 11-01
• Status: Recruiting
• Phase: Phase 2
• First received: April 11, 2011
• Last updated: March 2, 2013
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2013
• Source: Fudan University
• Contact: Ye Guo, MD
• Phone: 86 21 64175590
• Email: pattrick_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		6 weeks	No
Secondary	Median progression-free survival		1 year	No
Secondary	Median overall survival		1 year	No