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Phase II Open-label Study Evaluating Two Loading Regimens of Sunitinib Alternating With Cisplatin and Gemcitabine as Systemic Therapy for Locally Advanced or Metastatic Nasopharyngeal Carcinoma

Phase 2
21 Years
Open (Enrolling)
Nasopharyngeal Carcinoma

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Trial Information

Phase II Open-label Study Evaluating Two Loading Regimens of Sunitinib Alternating With Cisplatin and Gemcitabine as Systemic Therapy for Locally Advanced or Metastatic Nasopharyngeal Carcinoma

Inclusion Criteria:

- Patients may be included in the study only if they meet all of the following

- Male or female patients aged 21 years and above.

- Patients with histologically confirmed WHO Type II or III NPC.

- Tumour stage III, IVA (T4 N0-2 M0) or IVB (Any T N3 M0) or IVC (Any T Any N
M1)according to the American Joint Committee on Cancer (AJCC) 2010 criteria.
Alternatively, patients with locally advanced recurrent or metastatic NPC for
which systemic chemotherapy is indicated will be eligible.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

- Adequate organ function including the following:

a.Bone marrow function i.Haemoglobin = 9g/dl ii.Absolute neutrophil count (ANC)
= 1.5 x 109/L iii.Platelet count = 100 x 109/L.

b.Liver function i.Bilirubin < or = upper limit of normal (ULN) ii.Alkaline
phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) < or = 2.5x ULN
iii.Alanine transaminase (ALT) and aspartate transaminase (AST) < or = ULN
iv.Prothrombin time (PT) within the normal range for the institution.

c.Renal function i.Plasma creatinine within the normal range for the institution
or calculated creatinine clearance (by the Cockcroft-Gault formula) > 60mL/min.

d.Serum amylase and lipase < or = 1.5x ULN.

- Life expectancy of at least 3 months.

- Recovery from any previous drug- or procedure-related toxicity to National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
version 4.0 Grade 0 or 1 (except alopecia), or to baseline preceding the prior

- Signed informed consent obtained before any study specific procedure. Subjects
must be able to understand and be willing to sign the written informed consent.

Exclusion Criteria:

- Patients will be excluded from the study for any of the following reasons:

- Previous or concurrent anti-cancer chemotherapy, immunotherapy, radiotherapy or
any other investigational therapy.

- Patients who cannot swallow or patients with chronic gastrointestinal disease or
conditions that may hamper compliance and/or absorption of the tested product.

- Any concomitant condition that could compromise the objectives of this study
and/or the patient's compliance (eg. severe medical conditions such as
uncontrolled infection, poorly controlled diabetes mellitus, hypercalcaemia,
psychiatric disorders).

- Major thoracic and/or abdominal surgery in the preceding 3 weeks.

- Known human immunodeficiency virus (HIV) seropositivity, hepatitis B or C

- In the investigator's opinion, patients with a current or previous history of
clinically significant liver disease within the previous 2 years.

- History of cardiac disease: congestive heart failure > New York Heart
Association (NYHA) Class II; active coronary artery disease (unstable angina
[anginal symptoms at rest] or new-onset angina [began within the last 3 months]
or myocardial infarction within the past 6 months). Cardiac arrhythmias
requiring anti-arrhythmic therapy (ß-blockers or digoxin are permitted).

- Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90
mmHg, despite the use of = 3 anti-hypertensive drugs or systolic blood pressure
greater than 150 mmHg).

- Dehydration NCI-CTCAE Grade 2 or higher.

- Subjects with serious non-healing wound, ulcer, or bone fracture.

- Subjects with arterial or venous thrombotic or embolic events such as
cerebrovascular accident (including transient ischemic attacks), deep vein
thrombosis, or pulmonary embolism within the 6 months before start of study

- Subjects with renal impairment (creatinine clearance by the Cockcroft-Gault
formula) = 60mL/min) or on dialysis.

- Persistent proteinuria of NCI-CTCAE Grade 3 or higher (> 3.5 g/24 hours,
measured by urine protein/creatinine ratio on a random urine sample).

- Clinically significant bleeding (NCI-CTCAE Grade 3 or higher) within 30 days
prior to start of study medication.

- Subjects unable to swallow oral medications.

- Subjects with seizure disorder requiring anticonvulsant medication.

- History of organ allograft.

- Subjects with evidence or history of disorders of coagulation or thrombosis.

- Pregnancy or breastfeeding.

- Women of childbearing potential not employing adequate contraception. Women of
childbearing potential must have a pregnancy test performed a maximum of 7 days
before start of study medication, and a negative result must be documented
before start of study medication. Women of childbearing potential and men, must
agree to use adequate contraception (barrier method of birth control) upon
signing the informed consent form until at least 3 months after the last study
drug administration. The definition of adequate contraception will be based on
the judgment of the treating investigator or a designated associate.

- Substance abuse, medical, psychological or social conditions that may interfere
with the subject's participation in the study or evaluation of the study

- Known or suspected allergy to the investigational agent or any agent given in
association with this study.

- Any condition that is unstable or could jeopardize the safety or compliance of
the subject in the study.

- Previous or concurrent cancer which is distinct in primary site or histology
from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ,
treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1) or any
cancer curatively treated > 3 years prior to study entry.

- Interstitial lung disease with ongoing signs and symptoms at the time of

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Response

Outcome Description:

Rates of clinical response (complete and partial clinical response). Rates of pathological complete responses. Progression-free survival. Haematologic and non-haematologic toxicities, as well as serious adverse events.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Boon Cher Goh, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Nasopharyngeal Carcinoma
  • locally advanced
  • metastatic
  • Carcinoma
  • Nasopharyngeal Neoplasms