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

December 28, 2015 updated by: Li Zhang, Sun Yat-sen University

Multi-center, Randomized, Controlled, Open-label Study of Bevacizumab With Carboplatin and Paclitaxel Versus Carboplatin and Paclitaxel in Patients With Metastatic Nasopharyngeal Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

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
      • Dongguan, Guangdong, China
        • Recruiting
        • Dongguan People's Hospital
        • Contact:
        • Principal Investigator:
          • Chun Zhang
      • Guangzhou, Guangdong, China
        • Recruiting
        • First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
        • Principal Investigator:
          • Lizhu Lin
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yan Huang, MD
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Lizhu Lin, M.D.
      • Jiangmen, Guangdong, China
        • Recruiting
        • JiangMen Central Hospital
        • Contact:
        • Principal Investigator:
          • Xiaofan Ding
      • Shenzhen, Guangdong, China
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
        • Principal Investigator:
          • Guosheng Feng
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • Hainan General Hospital
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Carboplatin
Carboplatin AUC 6 IV Day 1 each 3-week cycle
Drug: Bevacizumab
Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle
Other Names:
  • AVASTIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival(PFS)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: 3 years
3 years
Number of Participants with Adverse Events
Time Frame: 3 years
3 years
Health-related quality of life
Time Frame: 3 years
3 years
Overall response rate (ORR,CR+PR)
Time Frame: 3 years
Identified by investigators and independent radiologic review (IRC) respectively
3 years
Disease control rate(DCR,CR+PR+SD)
Time Frame: 3 years
Identified by investigators and IRC respectively
3 years
Progression free survival(PFS)
Time Frame: 3 years
Identified by IRC
3 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29153

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.

Clinical Trials on Nasopharyngeal Neoplasms

Clinical Trials on Paclitaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe