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

NCT02360501 | Completed Phase 2

• 1 other identifier: DCX in NPC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Neoplasms

Keywords

nasopharyngeal carcinoma; induction chemotherapy; docetaxel; xeloda

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• complete response rate

  every 4 weeks,up to completion of treatment(approximately 6 months)

• 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）.

• 1 year overall survival rate

  date from diagnosis of NPC to death of any cause (up to 12 months)

• safety profiles (including hematologic toxicities and non-hematologic toxicities.)

  date from diagnosis of NPC to completion of study (about 6 months)

Study Arms (1)

treatment arm

EXPERIMENTAL

docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks

Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine

Interventions

Docetaxel DRUG

75mg/㎡,d1

Also known as: Taxotere

treatment arm

Cisplatin DRUG

25mg/㎡,d1-3

treatment arm

Capecitabine DRUG

2000mg/㎡,d1-14

Also known as: xeloda

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma

Interventions

Docetaxel; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Liang Wang, DOCTOR

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 10, 2015
• Study Start: January 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (1)