AzTrials
AzTrials

Head and Neck Squamous Cell CarcinomaPhase 2NCT01377298

Pazopanib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Pazopanib in people with Head and Neck Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity profile comparing with sunitinib, the investigators plan this phase II trial of pazopanib in cisplatin-refractory recurrent or metastatic HNSCC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTaiwan
Study dates
Jun 2011to May 2014
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed HNSCC.
  • Recurrent or metastatic setting, refractory to previous cisplatin or carboplatin-based chemotherapy.
  • At least one measurable lesion (according to RECIST v 1.1 criteria).
  • Eastern Cooperative Oncology Group performance status 0 to 2.
  • Age>18y/o,<=70y/o.
  • Adequate bone marrow, hepatic, and renal functions as evidenced by the following:
Show all 10Show fewer
  • Absolute neutrophil count>=1,500 cells/L, platelet count>=100,000 cells/L, and hemoglobin>=9 g/dL.
  • Total bilirubin<=1.5 X ULN, AST/ALT<=3.0 X ULN
  • Creatinine<=1.5 mg/dL.
  • Informed consent, obtained in writing.

Who cannot join

  • Second malignancy.
  • Locoregional recurrence amenable to definite surgery or radiation again.
  • Brain/meningeal metastasis with IICP or bone metastasis with spinal cord compression.
  • Pregnancy or nursing women.
  • Having received more than two prior lines of intravenous chemotherapy in the palliative setting.
  • Having received antiangiogenesis agent in the palliative setting.
Show all 26Show fewer
  • Having received chemotherapy or radiation therapy or surgery within 3 weeks.
  • Major systemic diseases those are inappropriate for systemic chemotherapy according to clinician's professional judgment.
  • Mental status not fit for clinical trials.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
  • Active peptic ulcer disease
  • Known intraluminal metastatic lesion/s with risk of bleeding
  • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
  • Corrected QT interval (QTc)>480 msecs using Bazett's formula.
  • Poorly controlled hypertension defined as SBP>=140 mmHg or DBP>=90mmHg
  • Concomitant diseases that might be aggravated by investigational drugs:
  • Active or non-controlled infection.
  • Severe upper gastrointestinal bleeding.
  • History of any one or more of the following cardiovascular conditions within the past 12 months:
  • Cardiac angioplasty or stenting,
  • Myocardial infarction,
  • Unstable angina,
  • Symptomatic peripheral vascular disease,
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Hemoptysis within 6 weeks of first dose of Pazopanib, prior major surgery within 4 weeks of first dose of Pazopanib, or presence of any non-healing wound/fracture.

Trial locations and contacts

1 site in 1 country.

Ruey-Long Hong, MD contact

+886 2 23123456 ext. 67510

rlhong@ntu.edu.tw

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Ruey-Long Hong, MD, +886 2 23123456 ext. 67510, rlhong@ntu.edu.tw

    Jo-Pai Chen, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase II Study of Pazopanib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Refractory to Platinum-Based Chemotherapy

Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity profile comparing with sunitinib, the investigators plan this phase II trial of pazopanib in cisplatin-refractory recurrent or metastatic HNSCC.

Read the detailed description

Pazopanib, a tyrosine kinase inhibitor targets VEGFR1/2/3, PDGFR alpha \& beta, c-KIT, and FGFR1/3 to inhibit angiogenesis. The phase II trial in advanced RCC (previous cytokine therapy in 25 % of patients) yielded good clinical benefits (response rate 34.6%; disease control 79.8%) with durable activity (progression-free to near 1 year) and acceptable toxicity. The randomized phase III trial in advanced RCC are ongoing and interim analysis revealed prolonged progression-free survival in pazopanib group compared with placebo group. Pazopanib is an active multi-targeted tyrosine kinase inhibitor needed to broaden it new indications to treat cancers. VEGF-C and FGF pathways are also important in the angiogenesis, metastasis, invasion, and cancer stem cell renewal in HNSCC. Pazopanib can also inhibit these two pathways and might offer much more suppression on tumor angiogenesis and growth in HNSCC compared with sunitinib. Common side effects of pazopanib are grade I to II diarrhea, hypertension, hair color change, and nausea, which are all manageable. Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity profile comparing with sunitinib, we plan this phase II trial of pazopanib in cisplatin-refractory recurrent or metastatic HNSCC.

Serum inflammation markers, like IL-6 (esp. in inflammation- mediated cancers, like virus- related hepatocellular carcinoma and HNSCC), and host/tumor VEGF/VEGFR2 polymorphism attracted much attention in tumor angiogenesis dependence and response prediction of anti-angiogenesis treatments, in addition to previously described sVEGFR2 and circulating endothelial progenitors(CEP) in the phase II trial of RCC. We will study serum IL-6/VEGF/sVEGFR2/CEP and host/tumor VEGF/VEGFR2 polymorphism for prognosis and response correlation.

Being tested
Pazopanib
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • PazopanibDrug

    200mg/tablet, 800mg/day PO.

Study groups in NCT01377298
Study groupRoleWhat they receive
PazopanibExperimentalSingle arm study, pazopanib
Receives: Drug: Pazopanib

What is being measured

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

  1. Objective response rate

    Evaluable for response: From the RECIST 1.1 paper,all patients included in the study must be accounted for in the results, even if there are major protocol treatment deviations or if they are not evaluable.

    Measured: 1 year

Secondary outcomes (4)

  1. disease control rate (CR+PR+SD),

    Patients who receive at least 3 days of pazopanib will be included in the baseline, dosing and safety summaries. The primary calculation of complete response rate will be based on all response-evaluable patients.

    Measured: 1 year

  2. Tumor Necrosis Ratio

    Tumor Necrosis Ratio: On contrast enhanced T1WI, (CE-T1WI), manual delineation of the area of necrosis and entire tumor is performed on the central tumor-containing slice with the areas of necrotic center and entire tumor automatically generated. The tumor necrosis ratio is defined as the area of necrotic center over that of the entire tumor.

    (<25%, <50%, <75%, or >75%)

    Measured: 1 year

  3. progression-free survival

    Measured: 1 year

  4. overall survival

    Measured: 1 year

Timeline

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

  1. First posted21 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2013 (estimated)
  4. Study completionMay 2014 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377298
Sponsor's protocol ID
201007042M
Status last verified
Jun 2011
First submitted
16 May 2011
Last updated
21 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib in people with Head and Neck Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

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 10 inclusion and 26 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 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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?

Contact Ruey-Long Hong, MD (+886 2 23123456 ext. 67510, rlhong@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 1 year). 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 NCT01377298.

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 21 Jun 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in