Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma

NCT00843037

Last updated date
Study Location
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Paraganglioma, Pheochromocytoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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

Paraganglioma, PheochromocytomaStudy Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma
NCT00843037
  1. Calgary, Alberta
  2. Toronto, Ontario
  3. Montreal, Quebec
  4. Groningen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Paraganglioma
  • Pheochromocytoma
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
 (submitted: April 3, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2009)
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:

  • 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Jennifer Knox, MD, FRCPCUniversity Health Network--Princess Margaret Cancer Centre
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