Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms Clinical Trial

Official title:

Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360501
• Other study ID #: DCX in NPC
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2015
• Last updated: April 18, 2016
• Start date: January 2008
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial Summary

The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.

Description:

The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• stage IVA and IVB nasopharyngeal carcinoma

• at lease one measurable lesion

• receive no chemotherapy or radiotherapy before

• Eastern CooperativeOncology Group performance status of 0 to 2.

• Adequate hematologic function (eg, white blood cell = 3×10e9/l,neutrophils count =1.5×10e9/L, and platelet count= 100×10e9/L),renal function (eg, serum creatinine=1.5 mg/dL and creatinine clearance =50 mL minute), and hepatic function (e.g, total bilirubin= 2 times the upper limit of normal and aspartate and alanine transaminase levels = 3 times the upper limit of normal)

Exclusion Criteria:

• mismatch the inclusion criteria

• previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

• allergy to any of these three drugs

Study Design

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

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms

Intervention

Drug:
• Docetaxel
75mg/?,d1
• Cisplatin
25mg/?,d1-3
• Capecitabine
2000mg/?,d1-14

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	overall response rate is the sum of complete response rate and partial response rate.	every 4 weeks,up to completion of treatment(approximately 6 months)	No
Secondary	complete response rate		every 4 weeks,up to completion of treatment(approximately 6 months)	No
Secondary	1 year progression free survival rate		date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first (up to 12 months).	No
Secondary	1 year overall survival rate		date from diagnosis of NPC to death of any cause (up to 12 months)	No
Secondary	safety profiles (including hematologic toxicities and non-hematologic toxicities.)	including hematologic toxicities (eg.the incidence rate of neutropenia,thrombocytopenia, and anemia), and non-hematologic toxicities (eg.edema, diarrhea, hand-foot-syndrome).	date from diagnosis of NPC to completion of study (about 6 months)	Yes