Status:
COMPLETED
Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Pfizer
Conditions:
Paraganglioma
Pheochromocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label phase II study of an investigational drug, sunitinib malate in patients with advanced malignant paraganglioma or phaeochromocytoma cancer. Paragangliomas (PGs) are tumours that a...
Detailed Description
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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 sunitinib
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00843037
Start Date
February 1 2009
End Date
March 14 2022
Last Update
October 17 2024
Active Locations (4)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
3
Hôpital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
4
University Medical Centre Groningen
Groningen, Netherlands