SOX as Salvage Treatment in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01403259
• Other study ID #: HNTG 11-02
• Status: Terminated
• Phase: Phase 2
• First received: July 26, 2011
• Last updated: August 19, 2014
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Fudan University
• Contact: n/a
• 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 SOX regimen (S-1 plus oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal carcinoma.

Description:

The treatment option in patients with platinum-resistant relapsed or metastatic nasopharyngeal carcinoma is limited. Previous studies showed that both S-1 and oxaliplatin were effective in head and neck cancer. Moreover, SOX (S-1 plus oxaliplatin) was proved to be tolerable in advanced stage gastric cancer. Therefore, we aim to evaluate this regimen in salvage setting of nasopharyngeal carcinoma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age range: 18-75 years old

• Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma

• Prior exposure of at least one line of platinum-containing regimen

• 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?50ml/min

• Without > 1 grade of neuropathy

Exclusion Criteria:

• With curable treatment option

• With CNS involvement

• Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy

• Treated with > 2 lines of palliative chemotherapy

• With prior exposure of S-1 or oxaliplatin

• 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
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• S-1 plus oxaliplatin
S-1 60 mg BID at day 1-14 Oxaliplatin 100 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	Median progression-free survival		1 year	No
Secondary	Overall response rate		6 weeks	No
Secondary	Median overall survival		1.5 year	No