Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

NCT01915134 | Unknown Phase 3 DMC

• 1 other identifier: ZhejaingCH-npc-03
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

Conditions

Effects of Chemotherapy; Stage IVC Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; Recombinant Human Endostatin; chemotherapy; gemcitabine and cisplatin

Outcome Measures

Primary Outcomes (1)

• progress free survival(PFS)

  PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.

  2years after the inception assignment

Secondary Outcomes (2)

• overall survival(OS)

  1 year ,2 years and 3 years after the inception of the assignment

• Adverse events

  participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years

Other Outcomes (1)

• The quality of life assessment

  participants will be followed for the duration of hospital stay,an expected average of 100 days and every 6 months thereafter for 3 years

Study Arms (2)

EGP group

EXPERIMENTAL

the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy

Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin

GP group

ACTIVE COMPARATOR

the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy

Drug: Gemcitabine and cisplatin

Interventions

Recombinant Human Endostatin plus gemcitabine and cisplatin DRUG

target therapy plus chemotherapy:4-6 cycles of Recombinant Human Endostatin plus gemcitabine and cisplatin:Endostatin：7.5mg/m2/d,d1-14,concomitant with chemotherapy for 4-6 cycles.Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.

Also known as: Experimental: EGP group

EGP group

Gemcitabine and cisplatin DRUG

only chemotherapy：Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.

Also known as: No Intervention: GP group

GP group

Eligibility Criteria

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

You may qualify if:

• metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up.

You may not qualify if:

• To give local treatment,clinical severe infection(\>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Zhejiang University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Endostatins; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Xiaozhong Chen

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Xiaozhong Chen

  Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaozhong Chen

CONTACT

86-571-88122098; cxzfyun@sina.com

Bin Li

CONTACT

86-571-88122091; libindoctor@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2013
• First Posted: August 2, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 1, 2015

Record last verified: 2013-07

Locations

CN (1)