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

April 18, 2016 updated by: Liang Wang, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment arm
docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks
Drug: Docetaxel
75mg/㎡,d1
Other Names:
  • Taxotere
Drug: Cisplatin
25mg/㎡,d1-3
Drug: Capecitabine
2000mg/㎡,d1-14
Other Names:
  • xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: every 4 weeks,up to completion of treatment(approximately 6 months)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response rate
Time Frame: every 4 weeks,up to completion of treatment(approximately 6 months)
every 4 weeks,up to completion of treatment(approximately 6 months)
1 year progression free survival rate
Time Frame: date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）.
date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）.
1 year overall survival rate
Time Frame: date from diagnosis of NPC to death of any cause (up to 12 months)
date from diagnosis of NPC to death of any cause (up to 12 months)
safety profiles (including hematologic toxicities and non-hematologic toxicities.)
Time Frame: date from diagnosis of NPC to completion of study (about 6 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCX in NPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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