Know Cancer

or
forgot password

Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Stage IV Nasopharyngeal Carcinoma

Thank you

Trial Information

Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma


Inclusion Criteria:



- Histologic diagnosis of nasopharyngeal carcinoma

- Distance metastasis at least 6 months after radical treatment

- Not suitable for local treatment, e.g. surgery, TACE

- At least one measurable lesion

- Estimate survival >3months

- Range from 18~70 years old

- PS 0~1

- WBC count ≥ 4×109/L,Hemoglobin ≥ 100g/L, platelet count ≥ 100×109/L

- ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN

- 0Serum creatinine < 1.5×ULN

Exclusion Criteria:

- Central nervous system metastases

- Suitable for local treatment

- Second malignancy within 5 years

- Precious therapy with an investigational agent

- Uncontrolled seizure disorder or other serious neurologic disease

- ≥ Grade Ш allergic reaction to any drug including in this study

- Clinically significant cardiac or respiratory disease

- Creatinine clearance < 30ml/min

- Drug or alcohol addition

- Do not have full capacity for civil acts

- Severe complication, active infection

- Concurrent immunotherapy or hormone therapy for other diseases

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate

Outcome Description:

To be determined by measurement of target lesions according to RECIST criteria

Outcome Time Frame:

study period of 19 Months

Safety Issue:

No

Principal Investigator

Chong Zhao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

PF-N-UMNPC

NCT ID:

NCT01616849

Start Date:

May 2012

Completion Date:

December 2013

Related Keywords:

  • Stage IV Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms

Name

Location