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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01333696

Enrollment

Registered

2011-04-12

Start date

2011-04-30

Completion date

2013-06-30

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Squamous cell carcinoma of head and neck, Pemetrexed

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.

Interventions

DRUGPemetrexed

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Overall response rate	6 weeks

Secondary

Measure	Time frame
Median progression-free survival	1 year
Median overall survival	1 year

Countries

China

Contacts

Primary ContactYe Guo, MD

pattrick_guo@msn.com86 21 64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026