Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- S-1 plus oxaliplatin
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Fudan University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Median progression-free survival
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Ye Guo
Dr.
Fudan University
Eligibility Criteria
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
Arms & Interventions
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 for 6 cycles
Intervention: S-1 plus oxaliplatin
Outcomes
Primary Outcomes
Median progression-free survival
Time Frame: 1 year
Secondary Outcomes
- Overall response rate(6 weeks)
- Median overall survival(1.5 year)