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Recurrent Lymphoepithelioma of the NasopharynxPhase 2NCT00454142

Pazopanib Hydrochloride in Treating Patients With Stage IV or Recurrent Nasopharyngeal Cancer

A Phase 2 study testing pazopanib hydrochloride, pharmacological study and computed tomography in people with Recurrent Lymphoepithelioma of the Nasopharynx and Recurrent Squamous Cell Carcinoma of the Nasopharynx, run by National Cancer Institute (NCI) at 3 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
pazopanib hydrochloride, pharmacological study and computed tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesSingapore
Study dates
Aug 2007to Aug 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed nasopharyngeal carcinoma, meeting the following criteria:
  • World Health Organization (WHO) type II-III disease
  • Stage IV or recurrent disease
  • Must have failed at least 1 prior line of chemotherapy for metastatic or recurrent disease
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
  • No known brain metastases
Show all 55Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 70-100%
  • Life expectancy > 3 months
  • WBC >= 3,000/mm³
  • Absolute neutrophil count >= 1,500/mm³
  • Platelet count >= 100,000/mm³
  • Bilirubin normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN)
  • Creatinine normal OR creatinine clearance >= 60 mL/min
  • Proteinuria =< 1+ on 2 consecutive dipsticks taken >= 1 week apart
  • Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.2 times ULN
  • Systolic blood pressure (BP) =< 140 mm Hg and diastolic BP =< 90 mm Hg
  • Initiation or adjustment of BP medication allowed provided the average of 3 BP readings are < 140/90 mm Hg prior to study entry
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or to other study agents
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No cerebrovascular accident within the past 6 months
  • No history of any of the following diseases within the past 12 weeks:
  • Myocardial infarction
  • Cardiac arrhythmia
  • Admission for unstable angina
  • Cardiac angioplasty or stenting
  • Venous thrombosis
  • No New York Heart Association (NYHA) class III-IV heart failure
  • Patients with a history of NYHA class II heart failure are eligible provided they are asymptomatic on treatment
  • No significant electrocardiogram (ECG) abnormalities, including QTc prolongation (i.e., QTc >= 500 msec)
  • No serious or non-healing wound, ulcer, or bone fracture
  • No condition that would impair the ability to swallow and retain pazopanib hydrochloride, including any of the following:
  • Gastrointestinal tract disease resulting in an inability to take oral medication
  • Requirement for IV alimentation
  • Prior surgical procedures affecting absorption
  • Active peptic ulcer disease
  • No concurrent uncontrolled illness including, but not limited to, the following:
  • Coagulopathy
  • Ongoing or active infection
  • Psychiatric illness or social situation that would preclude study compliance
  • No known allergy to CT contrast agents
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • More than 4 weeks since prior radiotherapy
  • At least 4 weeks since prior surgery
  • No prior antiangiogenesis therapy
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib hydrochloride, as determined by the Principal Investigator
  • No concurrent medications that have the potential to interact with the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4
  • No concurrent therapeutic warfarin
  • Low molecular weight heparin or prophylactic low-dose warfarin allowed
  • No concurrent antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Singapore3 sites

  • Cancer Therapeutics Research Group

    Singapore, 119074

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

About this study

Official title: A Phase 2 Study of GW786034 (Pazopanib) in Asian Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the efficacy of pazopanib hydrochloride in patients with stage IV or recurrent nasopharyngeal carcinoma.

II. Determine the progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the effect of this drug on angiogenesis inhibition using dynamic contrast-enhanced computed tomography (CT) scan.

  1. Determine the pharmacokinetic profile of this drug in these patients. VI. Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit rate and pharmacokinetics.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 12 months.

Being tested
pazopanib hydrochloride, pharmacological study, computed tomography

What participants receive

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

  • pazopanib hydrochlorideDrug

    Also called GW786034B, Votrient

    Given PO

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • computed tomographyProcedure or surgery

    Also called tomography, computed

    Correlative studies

Study groups in NCT00454142
Study groupRoleWhat they receive
Treatment (pazopanib hydrochloride)ExperimentalPatients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pharmacological study will be done on Day 1 and Day 28. Computed tomography will be done at baseline and day 28.
Receives: Drug: pazopanib hydrochloride; Other: pharmacological study; Procedure: computed tomography

What is being measured

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

  1. Clinical Benefit Rate

    Clinical benefit rate (CBR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST ver 1.0) and assessed by CT or MRI. CBR includes 1) Complete response (CR): disappearance of all lesions; 2) partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions and 3) stable disease (SD): non-PR and non progressive disease.

    Measured: 12 weeks of treatment

Secondary outcomes (11)

  1. Response Rate (PR)

    Per response evaluation criteria in solid tumors (RECIST v1.0) and assessed by MRI or CT: Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-PD (PD: progressive disease) of non-target lesions.

    Measured: 12 weeks of treatment

  2. Progression-free Survival

    Progression will be evaluated in this study using the new international criteria proposed by RECIST Committee. The sample proportion and associated 95% confidence interval will be reported.

    Measured: From the date of enrollment to the date of first documented progression or death, whichever occurs first, or to the date when the patient was last known to be alive, up to 3 years.

  3. Overall Survival

    Measured: From date of enrollment to the study to the date of death from any cause or to the date when the patient was last known to be alive, up to 3 years.

  4. Toxicity Profile: Percentage of Participants With Significant (Grade 3/4) Related Adverse Event (AE)

    The frequencies of grade 3/4 related toxicities were recorded among all participants, and the percentage of participants who experienced significant AEs were reported.

    Measured: From the time of first treatment with pazopanib hydrochloride to up to 30days after completion of treatment

  5. Pharmacodynamic Study: Tumor Blood Flow at Baseline

    Dynamic-contrast enhanced computed tomography (DCE-CT) was performed at baseline and Day 28, tumor blood flow was measured.19 of 33 patients had evaluable DCE-CT data.

    Measured: Pretreatment

  6. Pharmacodynamic Study: Tumor Blood Flow on Day 28

    DCE-CT was performed on Day 28 and tumor blood flow was measured. 19 of 33 patients had evaluable DCE-CT data.

    Measured: 28 days post treatment

  7. Pharmacokinetic Study: Percentage of Participants With Trough Concentration at Steady State (Day 28) Above 15 µg/mL

    Pazopanib pharmacokinetic parameters were estimated on Day 1 and Day 28 (steady state). Trough concentration of pazopanib was measured on Day 28 with blood sampling at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after Day 28 dose.

    Measured: Day 28 of treatment

  8. Pharmacokinetic Study: AUC0-24h/Dose on Day 1

    AUC 0-24h/dose were measured on day 1 for 26 evaluable participants. Blood sampling is done at zero (pre-dose), 0.5 hr, 1, 2, 3, 4, 5, 6 and 8 hrs after the first dose.

    Measured: Day 1 of treatment

  9. Pharmacokinetic Study: Area Under Curve (AUC) 0-24h/Dose on Day 28

    AUC 0-24h/dose were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.

    Measured: Day 28 of treatment

  10. Pharmacokinetic Study: Volume of Distribution (Vd/F/Dose) on Day 1

    Volume of distribution (Vd/F/dose) were measured on day 1 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 hrs after first dose.

    Measured: Day 1 of treatment

  11. Pharmacokinetic Study: Volume of Distribution at Steady State (Vss/F/Dose) on Day 28

    Volume of distribution at steady state (Vss/F/Dose) were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.

    Measured: Day 28 of treatment

Timeline

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

  1. First posted30 Mar 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionApr 2010
  4. Study completionAug 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00454142
Sponsor's protocol ID
NCI-2009-00197
Other IDs
NCI-2009-00197, CDR0000537520, CTRG-NP05/25/06, NCC-06-01, 7623
Status last verified
Jan 2012
First submitted
27 Mar 2007
Last updated
17 Dec 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib hydrochloride, pharmacological study and computed tomography in people with Recurrent Lymphoepithelioma of the Nasopharynx and Recurrent Squamous Cell Carcinoma of the Nasopharynx, run by National Cancer Institute (NCI) at 3 sites in Singapore.

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 55 inclusion and 0 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: finished, as of the sponsor's last update on 17 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 3 sites in Singapore. 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?

Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit Rate (time frame: 12 weeks of treatment). 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 NCT00454142.

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 17 Dec 2015.

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