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Nasopharyngeal NeoplasmsPhase 2NCT02250599

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

A Phase 2 study testing Paclitaxel, Bevacizumab and Carboplatin in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 8 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasopharyngeal Neoplasms
What is being tested?
Paclitaxel, Bevacizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
8 sitesChina
Study dates
Aug 2014to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites, 8 recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong

    Xuefang Zhang, 674854955@qq.com

    Chun Zhang

    Recruiting

  • Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

    Guangzhou, Guangdong, 510060

    li zhang, MD, 86-20-87343368, zhangli@sysucc.org.cn

    Tao Qin, 13570396232, tantao@sysucc.org.cn

    Recruiting

  • First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou, Guangdong

    Xuewu Huang, doctorhxw@sina.com

    Lizhu Lin

    Recruiting

  • Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong

    Xuewu Huang, M.D., doctorhxw@sina.com

    Lizhu Lin, M.D.

    Recruiting

  • Hainan General Hospital

    Haikou, Hainan

    Yanju Chen, cyj-0001@163.com

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

    Yu Wang, 39672979@qq.com

    Xiaofan Ding

    Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

    Zhiyong Xu, 18978187401@189.cn

    Guosheng Feng

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Ruilian Xu, xuruilian@126.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Keywords
Metastatic Nasopharyngeal Carcinoma, treatment
Medical subject headings
Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle

  • BevacizumabDrug

    Also called AVASTIN

    Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle

  • CarboplatinDrug

    Carboplatin AUC 6 IV Day 1 each 3-week cycle

Study groups in NCT02250599
Study groupRoleWhat they receive
carboplatin and paclitaxelActive comparatorcarboplatin and paclitaxel :paclitaxel 175 mg/m2 IV and carboplatin AUC 6 IV on Day 1 of each 3-week cycle
Receives: Drug: Paclitaxel; Drug: Carboplatin
AVASTIN and carboplatin and paclitaxelExperimentalAVASTIN 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
Receives: Drug: Paclitaxel; Drug: Bevacizumab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival(PFS)

    Measured: 3 years

Secondary outcomes (6)

  1. Overall survival(OS)

    Measured: 3 years

  2. Overall response rate (ORR,CR+PR)

    Identified by investigators and independent radiologic review (IRC) respectively

    Measured: 3 years

  3. Disease control rate(DCR,CR+PR+SD)

    Identified by investigators and IRC respectively

    Measured: 3 years

  4. Health-related quality of life

    Measured: 3 years

  5. Number of Participants with Adverse Events

    Measured: 3 years

  6. Progression free survival(PFS)

    Identified by IRC

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionApr 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02250599
Sponsor's protocol ID
ML29153
Status last verified
Dec 2015
First submitted
26 Aug 2014
Last updated
30 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhou T, Yang Y, Ma S, Lin L, Zhou T, Zhang C, Ding X, Wang R, Feng G, Chen Y, Xu R, Huang Y, Zhang L. Bevacizumab versus placebo in combination with paclitaxel and carboplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase II trial. ESMO Open. 2021 Dec;6(6):100313. doi: 10.1016/j.esmoop.2021.100313. Epub 2021 Nov 24.

    PubMed 34837744

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Bevacizumab and Carboplatin in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02250599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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