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Efficacy and Safety of TC+AVASTIN Versus TC in Patients With Metastatic Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02250599
Recruitment Status : Unknown
Verified December 2015 by Li Zhang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 26, 2014
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Study Description
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Brief Summary:
The present study will be a randomized, control, multicenter phase II study of metastatic nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H&N35 are used to measure PRO outcome for this study.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Drug: Paclitaxel Drug: Bevacizumab Drug: Carboplatin Phase 2

Detailed Description:

Nasopharyngeal carcinoma is vastly more common in East Asia, especially China has a high incidence of it, and the number of new cases will account for more than 40% of the world total . The disease involved population maybe more than 4 million in the world. More than 2700-3000 new nasopharyngeal carcinoma patients will be diagnosed in SUN YAT-SEN university cancer center every year. It is most common in 40-50 years old adults and has been a top ten (10th) malignant tumor in Chinese male which threaten human health and social economy.

Chemotherapy is the standard treatment of the advanced nasopharyngeal carcinoma.Several other phase II study also confirmed the effectiveness of paclitaxel and carboplatin （TC） regimen in advanced NPC, so it maybe a simple right choice.

Increasing expression of VEGF in serum associated with poor prognosis in metastatic nasopharyngeal carcinoma. Agents that selectively target VEGF-A and its receptors have shown significant antitumor effects in xenograft models of nasopharyngeal. Studies demonstrated that bevacizumab（AVASTIN） administration with chemotherapy or chemoradiation is feasible in patients with nasopharyngeal cancer. Bevacizumab can be safely combined with a range of cytotoxic and other anticancer agents including TC regimen.

Evidence indicated a potential possibility that the TC+AVASTIN regimen may be superior than TC regimen.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Controlled, Open-label Study of Bevacizumab With Carboplatin and Paclitaxel Versus Carboplatin and Paclitaxel in Patients With Metastatic Nasopharyngeal Carcinoma
Study Start Date : August 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: carboplatin and paclitaxel
carboplatin and paclitaxel :paclitaxel 175 mg/m2 IV and carboplatin AUC 6 IV on Day 1 of each 3-week cycle
 Drug: Paclitaxel
Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle

Drug: Carboplatin
Carboplatin AUC 6 IV Day 1 each 3-week cycle
Experimental: AVASTIN and carboplatin and paclitaxel
AVASTIN and carboplatin and paclitaxel: Bevacizumab(AVASTIN) 7.5 mg/kg intravenously (IV) infusion on Day 1 of each 3-week cycle; paclitaxel 175 mg/m2 IV and carboplatin AUC 6 IV on Day 1 of each 3-week cycle
 Drug: Paclitaxel
Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle

Drug: Bevacizumab
Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle
Other Name: AVASTIN

Drug: Carboplatin
Carboplatin AUC 6 IV Day 1 each 3-week cycle


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 3 years ]
  2. Overall response rate (ORR,CR+PR) [ Time Frame: 3 years ]
    Identified by investigators and independent radiologic review (IRC) respectively

  3. Disease control rate(DCR,CR+PR+SD) [ Time Frame: 3 years ]
    Identified by investigators and IRC respectively

  4. Health-related quality of life [ Time Frame: 3 years ]
  5. Number of Participants with Adverse Events [ Time Frame: 3 years ]
  6. Progression free survival(PFS) [ Time Frame: 3 years ]
    Identified by IRC


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet the following criteria for study entry:
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status 0~1
  • Patients with a life expectancy>12 weeks
  • Histologically proven NPC diagnosis
  • Metastatic nasopharyngeal carcinoma with evidence of unsuitable for local treatment(in terms of some relevant therapy for anti-tumor like surgery, radiofrequency ablation, transcatheter arterial chemoembolization(TACE) and radiotherapy(except palliative radiotherapy for metastatic bone pain with appropriate radiation dosage without influence to the hemogram),etc.)

  • Neoadjuvant or concurrent chemoradiotherapy was allowed, provided that the treatment was completed at least 3 months before the start of study drug treatment

    -≥1 measurable target based on RECIST criteria

  • Adequate bone marrow, hepatic and renal function, defined as follows within 1 weeks prior to randomization
  • Patients must sign study specific informed consent prior to registration
  • Patient must have recovered (be >28 days post-surgery) from the effects of surgery, postoperative infection, and other complications before initial treatment with bevacizumab
  • Systolic blood pressure ≤ 160 mmHg and diastolic pressure ≤ 90 mmHg within 7 days prior to randomization.

Exclusion Criteria:

  • Prior systemic treatment for metastatic nasopharyngeal carcinoma
  • Preparing for receiving local treatment for metastatic nasopharyngeal carcinoma (excluding palliative irradiation to release skeletal pain)
  • Prior treatment with bevacizumab or other agents specifically targeting VEGF
  • Patients with hemorrhage tendency including acute hemorrhage of digestive tract, nasal bleeding （not including nasal epistaxis), continuous hemorrhagic disease or Coagulation function disorder disease. Patients are using known NSAIDS to inhibit platelets.
  • Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon or more or frank clots within minimal or no phlegm per coughing episode) within 4 weeks prior to registration; patients with incidental blood mixed with phlegm are not excluded
  • Patients receiving other experimental therapeutic cancer treatment

  • Severe, active co-morbidity, defined as follows:

    i.--Unstable angina and/or congestive heart failure or vascular (e.g. aortic aneurysm requiring surgical repair or peripheral thrombosis) disease requiring hospitalization within the last 12 months, or other cardiac compromise (e.g. an inadequately controlled cardiac arrhythmia) that in the judgment of the investigator will preclude the safe administration of a study drug; Patient must not show sign of recent myocardial infarction or ischemia by the findings of S-T elevations of ≥ 2mm on an EKG ii.--History of arterial thromboembolic events, venous thromboembolism >NCI CTCAE Grade 3, transient ischemic attack (TIA), cerebral vascular accident (CVA), transmural myocardial infarction (MI), or hypertensive crisis or hypertensive encephalopathy iii.--History of ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy iv.--Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration v.--History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active GI bleeding within the last 6 months prior to registration; vi.--Esophageal varices, non-healing ulcer, non-healing wound, or bone fracture within the last 6 months prior to registration vii.--Active, untreated infection and/or acute bacterial or fungal infection uiring intravenous antibiotics at the time of registration viii.--Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; ix. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects x. - Minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment

  • Patients currently (within 10 days of study enrollment) taking warfarin, heparin, daily treatment with aspirin (> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function; treatment with dipyramidole, ticlopidine, clopidogrel, or cilostazol
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception;
  • Prior allergic reaction to the study drug(s) involved in this protocol
  • Contraindication to Bevacizumab
  • Patients has another cancer history （not NPC）within 5 years before randomization.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250599


Locations
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China, Guangdong
Dongguan People's Hospital Recruiting
Dongguan, Guangdong, China
Contact: Xuefang Zhang       674854955@qq.com   
Principal Investigator: Chun Zhang         
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: li zhang, MD    86-20-87343368    zhangli@sysucc.org.cn   
Contact: Tao Qin    13570396232    tantao@sysucc.org.cn   
Sub-Investigator: Yan Huang, MD         
First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China
Contact: Xuewu Huang       doctorhxw@sina.com   
Principal Investigator: Lizhu Lin         
Guangzhou University of Chinese Medicine Recruiting
Guangzhou, Guangdong, China
Contact: Xuewu Huang, M.D.       doctorhxw@sina.com   
Principal Investigator: Lizhu Lin, M.D.         
Jiangmen Central Hospital Recruiting
Jiangmen, Guangdong, China
Contact: Yu Wang       39672979@qq.com   
Principal Investigator: Xiaofan Ding         
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Ruilian Xu       xuruilian@126.com   
China, Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China
Contact: Zhiyong Xu       18978187401@189.cn   
Principal Investigator: Guosheng Feng         
China, Hainan
Hainan General Hospital Recruiting
Haikou, Hainan, China
Contact: Yanju Chen       cyj-0001@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: li zhang, MD Sun Yat-sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02250599    
Other Study ID Numbers: ML29153
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015
Keywords provided by Li Zhang, Sun Yat-sen University:
Metastatic Nasopharyngeal Carcinoma
treatment
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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
Paclitaxel
 Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors