Know Cancer

or
forgot password

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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Squamous Cell Carcinoma of Head and Neck

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

HNTG 11-01

NCT ID:

NCT01333696

Start Date:

April 2011

Completion Date:

June 2013

Related Keywords:

  • Squamous Cell Carcinoma of Head and Neck
  • Squamous cell carcinoma of head and neck
  • Pemetrexed
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location