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SOX as Salvage Treatment in Nasopharyngeal Carcinoma

This study is currently recruiting participants.
Verified March 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01403259
First received: July 26, 2011
Last updated: March 2, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
 Drug: S-1 plus oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Oxaliplatin
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Median progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: 1.5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 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
Other Names:
  • S-1
  • Oxaliplatin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403259

Contacts
Contact: Ye Guo, MD 86 21 64175590 ext 8906 pattrick_guo@msn.com

Locations
China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Ye Guo, MD     86 21 64175590 ext 8906     pattrick_guo@msn.com    
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

No publications provided

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT01403259     History of Changes
Other Study ID Numbers: HNTG 11-02
Study First Received: July 26, 2011
Last Updated: March 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Nasopharyngeal carcinoma
S-1
Oxaliplatin

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013