NCT01340794

Brief Summary

This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Typical duration for phase_2

Geographic Reach
3 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 21, 2016

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

3.5 years

First QC Date

April 21, 2011

Results QC Date

March 23, 2016

Last Update Submit

September 19, 2017

Conditions

Extra-Adrenal ParagangliomaMetastatic Adrenal Gland PheochromocytomaParagangliomaRecurrent Adrenal Gland Pheochromocytoma

Outcome Measures

Primary Outcomes (1)

  • Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1

    Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1) Ninety-five percent confidence intervals for the true response proportion was calculated using the exact binomial test. Complete Response (CR): All of the following must be true: 1. Disappearance of all target and non-target lesions. 2. Each lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking baseline measures as reference. Overall Response (OR) was calculated by summing the number of patients with a CR or PR.

    Up to 5 years

Secondary Outcomes (4)

  • Duration of Tumor Response

    Up to 5 years

  • Overall Survival Time

    The time from registration to death due to any cause, assessed up to 5 years

  • Progression-free Survival Time

    The time from registration to documentation of disease progression or death, whichever occurs first, assessed up to 5 years

  • Time to Treatment Failure

    Up to 5 years from registration

Study Arms (1)

Treatment (pazopanib hydrochloride)

EXPERIMENTAL

Patients receive pazopanib hydrochloride PO QD on days 1-28 (days 1-14 of courses 1 and 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Pazopanib Hydrochloride

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (pazopanib hydrochloride)
Pazopanib HydrochlorideDRUG

Given PO

Also known as: GW786034B, Votrient
Treatment (pazopanib hydrochloride)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed malignant secretory or non-secretory pheochromocytoma or paraganglioma that is unresectable and deemed inappropriate for alternative local regional therapeutic approaches
  • Objective evidence of tumor progression =\< 185 days prior to registration as assessed by:
  • Unequivocal progression of objectively measured disease on successive appropriate imaging (e.g. computed tomography \[CT\] scan); in cases of uncertainty of tumor progression, the principal investigator of the study will be available to assist in decisions
  • Measurable disease defined as:
  • At least one non-nodal lesion whose longest diameter can be accurately measured as \>= 2.0 cm with chest x-ray, or as \>= 1.0 cm with CT scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI); and/or
  • A lymph node whose short axis must be \> 1.5 cm when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm)
  • Note: Tumor lesions in a previously irradiated area are not considered measurable disease
  • Life expectancy \> 24 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  • Leukocytes \>= 3,000/uL
  • Absolute neutrophil count \>= 1,500/uL
  • Platelets \>= 100,000/uL
  • Hemoglobin \>= 9 g/dL (5.6 mmol/L); transfusions not permitted =\< 7 days of registration
  • Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (except in cases of Gilbert's syndrome, where indirect bilirubin may be elevated, but the direct bilirubin remains within 1.5 x ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN
  • +10 more criteria

You may not qualify if:

  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception NOTE: breastfeeding should be discontinued if the mother is treated with pazopanib (GW786034)
  • Any of the following:
  • Chemotherapy/systemic therapy =\< 4 weeks prior to registration
  • Radiotherapy =\< 4 weeks prior to registration
  • Surgery =\< 4 weeks prior to registration
  • Nitrosoureas or mitomycin C =\< 6 weeks prior to registration
  • Those who have not recovered from adverse events due to agents administered more than 4 weeks earlier NOTE: Concurrent therapy with octreotide is allowed providing that tumor progression on this therapy has been demonstrated; concurrent therapy with bisphosphonates (e.g. zoledronic acid) or denosumab is also allowed.
  • NOTE: An unlimited number of prior chemotherapeutic or biologic therapies for malignant pheochromocytoma or paraganglioma is permitted; this includes prior anti-angiogenesis therapies such as tyrosine kinase inhibitors
  • Any other ongoing investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib (GW786034) or other agents used in the study
  • Any of the following:
  • Corrected QT (QTc) prolongation (defined as a QTc interval \>= 500 msecs)
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Metro-Minnesota NCI Community Oncology Research Program

Saint Louis Park, Minnesota, 55416, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Chinese University of Hong Kong-Prince of Wales Hospital

Shatin, OX1 3UJ, Hong Kong

Location

National University Hospital Singapore

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Paraganglioma, Extra-AdrenalPheochromocytomaParaganglioma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Results Point of Contact

Title
Keith Bible, M.D., Ph.D.
Organization
Mayo Clinic Cancer Center
bible.keith@mayo.edu

Study Officials

  • Keith Bible

    Mayo Clinic Cancer Center P2C

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 25, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 21, 2017

Results First Posted

July 21, 2016

Record last verified: 2017-09

Locations

SG(1)US(9)HK(1)