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A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma

Phase 2
18 Years
Open (Enrolling)
Paraganglioma, Pheochromocytoma

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Trial Information

A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma

This study will be a single arm, open-label, phase II trial of sunitinib in patients with
metastatic or locally advanced malignant paraganglioma or phaeochromocytoma. Oral sunitinib
(50 mg) will be administered to all patients daily for the first four weeks of a six week
study cycle, followed by a 2-week rest. Patients will be assessed for response to study
treatment using MRI/CT scans as well as bio-chemical tests, and will receive the study
treatment for up to 12 months or until disease progression.

Primary study outcomes include:

To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6
weeks in patients with advanced or metastatic paraganglioma/ pheochromocytoma.

To assess the toxicity of sunitinib in patients with advanced or metastatic paraganglioma/

To document effects of sunitinib on markers of biochemical activity of advanced or
metastatic paraganglioma/ pheochromocytoma.

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of malignant paraganglioma or
pheochromocytoma and either evidence of metastases or unresectability.

- Evidence of recent disease progression (radiological, biochemical, symptomatic).

- Measurable disease defined as that which can be measured in at least one dimension
with a minimum size of 10 mm by CT scan.

- ECOG 0-2.

- Life expectancy of greater than 24 weeks.

- Age > 18 years.

- Patients must have normal organ and marrow function.

- Patients must have PT/INR/PTT within 1.2 X the upper limit

- Patients may have had prior radiation therapy. A minimum of 28 days must have elapsed
between the end of radiotherapy and registration onto the study.

- Previous Surgery: Previous major surgery is permitted provided that it has been at
least 28 days prior to patient registration

- Laboratory Requirements Parameter Limit granulocytes (AGC) > 1.5 x 109/L platelets >
100 x 109/L bilirubin < 1.5XULN AST and ALT < 2.5 x ULN Amylase <1.5XULN Lipase
<1.5XULN Calcium < 3 mmol/L creatinine < 2.0XULN

Exclusion Criteria:

- History of other malignancies.

- Patients with known brain metastases.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sunitinib.

- Patients receiving concurrent treatment with other anti-cancer therapy given for
paraganglioma or pheochromocytoma or other therapy or other investigational
anticancer agents.

- Patients who have received prior treatment with any other antiangiogenic agent or
multi-targeted tyrosine kinase inhibitors are ineligible.

- Patients with any of the following cardiovascular findings are to be excluded:

- QTc prolongation or other significant ECG abnormalities.

- Current or history of Class III or IV heart failure as defined by the NYHA functional
classification system

- Patients with prior anthracycline exposure, previous central thoracic radiation that
included heart in radiation port, or a history of NYHA Class II cardiac function.

- Poorly controlled hypertension

- Myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic
congestive heart failure, or coronary/peripheral artery bypass graft or stenting
within 12 months prior to study entry

- History of venous thrombosis or pulmonary embolism in the past 3 months

- History of cerebrovascular accident (CVA) or transient ischemic attack within 12
months prior to study entry

- Patients who require use of therapeutic doses of coumarin-derivative anticoagulants
such as warfarin

- Patients with bowel obstruction or any condition that impairs their ability to
swallow and retain sunitinib tablets.

- Use of agents with proarrhythmic potential is not permitted during the study.

- Must be able to stop prohibited selected CYP3A4 inhibitors/inducers prior to starting

- Patients with pre-existing hypothyroidism prior to enrolment are ineligible unless
they are euthyroid on medication.

- Pregnant or lactating women, positive pregnancy test, women of childbearing potential
who do not agree to use adequate contraception prior to study entry and for the
duration of study participation.

- Known HIV-positive patients on combination antiretroviral therapy

- Greater than +1 proteinuria on urinary dipstick if also >1g urinary protein/24hrs

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit rate (CBR) which is defined as either a partial response (PR) complete response (CR) or stable disease (SD) for ≥ 12 weeks measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Outcome Time Frame:

Every 12 weeks (2 cycles)

Safety Issue:


Principal Investigator

Jennifer Knox, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Health Canada

Study ID:




Start Date:

February 2009

Completion Date:

December 2013

Related Keywords:

  • Paraganglioma
  • Pheochromocytoma
  • Metastatic or locally advanced malignant paraganglioma
  • Metastatic or locally advanced malignant pheochromocytoma
  • Paraganglioma
  • Pheochromocytoma