Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma
NCT00843037
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Calgary, Alberta
- Toronto, Ontario
- Montreal, Quebec
- Groningen,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma | |||
Official Title ICMJE | A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma | |||
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 arise from the para-sympathetic system in the head and neck and sympathetic system in the thorax and abdomen. Paragangliomas that secrete hormones (catecholamines) from the adrenal glands are called pheochromocytomas (PCs). In this study, patients whose disease has advanced or spread despite prior standard therapy, will receive sunitinib for 4-weeks followed by a 2-week rest period, for up to 12 months, in the absence of disease progression. Sunitinib is an investigational drug, which has been shown to shrink tumours in several tumour models. The study will evaluate the efficacy as well as the toxicity profile of sunitinib when used as an alternative treatment for patients with PG/PC tumours. | |||
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 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/ pheochromocytoma. To document effects of sunitinib on markers of biochemical activity of advanced or metastatic paraganglioma/ pheochromocytoma. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Sunitinib
50 mg oral dose daily for 4 weeks, 2 week rest period (repeating 6 week cycles) Other Name: Sunitinib malate (suntinib; SU11248, SU011248, Sutent®) | |||
Study Arms ICMJE | Experimental: Open label - Sunitinib
Sunitinib, 50mg daily, once daily for 4 weeks followed by a 2-week break Intervention: Drug: Sunitinib | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE | 25 | |||
Original Estimated Enrollment ICMJE | 28 | |||
Estimated Study Completion Date ICMJE | May 2021 | |||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00843037 | |||
Other Study ID Numbers ICMJE | SNIPP | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University Health Network, Toronto | |||
Study Sponsor ICMJE | University Health Network, Toronto | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | University Health Network, Toronto | |||
Verification Date | September 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |